|Year : 2021 | Volume
| Issue : 2 | Page : 76-86
Role of Haratala Shodhana in the therapeutic efficacy of Rasamanikya along with Guduchi Ghana in the treatment of Ekakushtha (psoriasis): A double-blind randomised clinical trial
Dipali Narendrakumar Parekh1, Dharmishtha Bopaliya2, Dilipkumar Prajapati1, Prashant Bedarkar1, BJ Patgiri1
1 Department of Rasa Shastra and Bhaishajya Kalpana, Institute of Teaching and Research in Ayurveda, Jamnagar, Gujarat, India
2 Department of Rasa Shastra and Bhaisjaya Kalpana, B. G. Garaiya Ayurveda College, Rajkot, Gujarat, India
|Date of Submission||31-Aug-2021|
|Date of Decision||27-Jul-2022|
|Date of Acceptance||07-Oct-2022|
|Date of Web Publication||16-Mar-2023|
Dipali Narendrakumar Parekh
Department of Rasa Shastra and Bhaishajya Kalpana, Institute of Teaching and Research in Ayurveda, Jamnagar - 361 008, Gujarat
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Introduction: Rasamanikya (RM) and Guduchi Ghana (GG) are well-known formulations for treating skin disorders in Ayurveda. The drug RM is prepared from Shuddha Haratala (processed orpiment) as a single ingredient. In the present study, RM was prepared from the Haratala, which was Shodhita, with two different media, viz., Kushmanda Swarasa and Churnodaka. In the classics, the preparation of RM is mentioned in the Kushmanda Shodhita Haratala. However, the availability and cost of Kushmanda are the main points of concern in the present era. Shodhana of Haratala by Churnodaka is more cost-effective than Kushmanda Swarasa. Aim: The aim of this study is to evaluate the comparative efficacy of RM prepared by Churnodaka Shodhita Haratala (CSHRM) and RM prepared by Kushmanda Shodhita Haratala (KSHRM) with GG in Ekakustha (psoriasis). Materials and methods: The study was a randomized double-blind study involving 76 patients with Ekakushtha that were randomly divided into two groups. Patients registered in group A (n = 37) were treated with CSHRM with GG (125 mg + 375 mg) and group B (n = 36) with KSHRM with GG (125 mg + 375 mg) for 8 weeks. The Wilcoxon signed rank test and paired t-test were applied to evaluate the effect of therapy in the individual group for subjective criteria like the PASI score, Matsyashakalopamam (looks like the scales of a fish), Rukshata (dryness), Aswedanam (anhydrosis), Daha (burning), Strava (discharge), Unnati (raised patches), Kandu (itching), Mahavastu (broad-based), and Vaivarnya (discoloration), while the comparison of results between the groups for the same was done by applying the Coefficient of Variation (CV). Result: CSHRM with GG showed better results in all signs and symptoms except Matsyaskalopamam, Aswedanam, Strava, Mahavastu, Nindra and DLQI in terms of the coefficient of variation. In both groups, statistically highly significant (P > 0.001) improvement was found in the signs and symptoms of Ekakushtha. However, the difference between the groups was statistically nonsignificant. Conclusion: Rasamanikya prepared with both media Shodhita Haratala along with Guduchi Ghana was discovered to be a safe and effective psoriasis treatment.
Keywords: Ekakushtha, Guduchi Ghana, Haratala, orpiment, psoriasis, Rasamanikya
|How to cite this article:|
Parekh DN, Bopaliya D, Prajapati D, Bedarkar P, Patgiri B J. Role of Haratala Shodhana in the therapeutic efficacy of Rasamanikya along with Guduchi Ghana in the treatment of Ekakushtha (psoriasis): A double-blind randomised clinical trial. AYU 2021;42:76-86
|How to cite this URL:|
Parekh DN, Bopaliya D, Prajapati D, Bedarkar P, Patgiri B J. Role of Haratala Shodhana in the therapeutic efficacy of Rasamanikya along with Guduchi Ghana in the treatment of Ekakushtha (psoriasis): A double-blind randomised clinical trial. AYU [serial online] 2021 [cited 2023 Mar 30];42:76-86. Available from: https://www.ayujournal.org/text.asp?2021/42/2/76/371808
| Introduction|| |
Rasamanikya (RM) is one of the familiar medicaments used by Ayurvedic physicians to treat various disorders such as Jwara (fever), Kasa (cough), Shwasa (dyspnea), Arsha (haemorrhoids), Bhagandara (fistula-in-ano), and Kushtha (integumentary disease). Shuddha Haratala (processed orpiment) is the only component of RM. Processed orpiment has Katu (bitter) and Kashaya (astringent) Rasa (taste), Ushna Veerya (hot in potency), and Katu Vipaka (biotransformed in bitter taste). It possesses a Snigdha (slimy) property and is used for Rasayana (rejuvenation). Ekakushtha is classified under Kshudra Kushtha by all the Acharyas of Ayurveda. According to Ayurveda, it is Vata Kapha Dosha Pradhana Vyadhi. It has been correlated with psoriasis by previous researchers. Psoriasis is defined as an autoimmune, chronic inflammatory disease of the skin. The worldwide prevalence of psoriasis is estimated to be approximately 2–3%. Modern medical science treats psoriasis with psoralen plus ultraviolet (UV)-A radiation treatment and corticosteroids. However, the therapy has serious side effects, such as liver and kidney failure and bone marrow depletion. Hence, it is time to find a safe and effective medicine for psoriasis, and here comes the role of Ayurveda. Previously, pharmaceutical studies on RM and various clinical studies on Ekakushtha have been carried out in various institutes. Till date, no research has been carried out to find out the efficacy of RM along with Guduchi Ghana (GG) in psoriasis or the role of Shodhana media in the preparation of RM. Therefore, an attempt has been made to find out the results of these drugs.
| Materials and methods|| |
The study was approved by the institutional ethics committee (7-A/Ethics/2017-18/2069/2.10, dated November 21, 2017) and registered with the clinical trial registry of India, ICMR, New Delhi (see Registration No. CTRI/2018/01/011151 dated January 5, 2018) and conducted at IPGT and RA, GAU, Jamnagar, India. The study was randomised and double-blind, involving 76 patients with psoriasis who fulfilled the inclusion criteria. Each patient was examined in detail. Relevant pathological (total leukocyte count [TLC], differential leukocyte count [DLC], hemoglobin [Hb], erythrocyte sedimentation rate[ESR], total red blood cell [T- RBC], absolute eosinophil count [AEC] etc.) and biochemical investigations (fasting blood sugar [FBS], Serum glutaminic-oxaloacetic transaminase [SGOT], Serum glutamic pyruvic transaminase [SGPT], and alkaline phosphate, serum creatinine, and blood urea etc.) were done before and after treatment to assess the disease condition and to exclude any other pathology. Informed consent was taken from all the patients before they were included in the trial.
Patients having classical signs and symptoms of Ekakushtha (psoriasis) like Aswedanam (anhydrosis), Mahavastu (broad based), and Matsyashakalopamam (which looks like the scales of a fish) were included in the study. Patients having an age range between 18 to 60 years, irrespective of gender, and a chronicity of upto 10 years were included.
Patients who have had a chronic illness for more than ten years, patients with cardiac, renal, and hepatic diseases, and patients with other conditions such as insulin-dependent diabetes mellitus (IDDM), non-IDDM, pregnant and lactating women, and women of reproductive age planning to conceive within the next three months were unfitted for trial. Sarva Linga Yukta (having all the symptoms of Kustha), Trushna (thirsty), Daha (burning sensation), Shantagni (satiated digestive power), and Jantubhijdham (worm-eaten) were all the symptoms ruled out.
Method of preparation of trial drug
The Kacha Kupi (glass bottle) was filled with powder (#40) of processed orpiment (Shuddha Haratala) after three layers of clay & cotton cloth (Kapadmitti) smear on a glass bottle. A filled glass bottle was kept in the EMF. The temperature of the EMF was settled at 400 °C. EMF was turned off once the orpiment had completely melted. After self-cooling, the final product was collected from the bottom of the glass. Guduchi Kwatha is prepared from fresh Guduchi, and after that, it is again boiled to a semi-solid consistency. Then it was dried under sunlight and the powder was prepared. Then the Rasamanikya and Guduchi Ghana were mixed properly, and the capsules were filled.
Posology and revealing the blinding
There were 76 registered patients in the study. Eighty participants were randomly divided into blocks of 40:40. To replicate this plan, use seed 30 (created on July 6, 2018, at 7:01 p.m. from http://www.randomization.com). Both groups were treated with capsules prepared with 125 mg RM and 375 mg GG. Patients have to open that capsule and take it with honey and Goghrita twice a day. The treatment protocol was followed for 8 weeks, with a follow-up of 4 weeks. Other medicines were stopped, and dietary restrictions had been advised in both groups, as stated in the classics. Patients were treated with the internal administration of trial drugs A and B in groups A (n = 37) and B (n = 36), respectively. The blinding was unveiled after a complete statistical analysis of the obtained data. After revealing the blinding, drug A was found to be RM prepared with Churnodaka Shodhita Haratala (CSH) with GG, and drug B was RM prepared with Kushmanda Swarasa Shodhita Haratala (KSH) with GG.
Criteria for assessment
Subjective criteria involved the chief complaints such as Matsyashakalopamam (looks like the scales of a fish), Rukshata (dryness), Aswedanam (anhydrosis), Daha (burning), Strava (discharge), Unnati (raised patches), Kandu (itching), Mahavastu (broad based), Vaivarnya (discoloration), and associated complaints such as Jwara (fever), Nindra (sleep), Sandhishoola (joint pain), and Nakhadushti (involvement of nails). The candle grease sign and Auspitz sign were also evaluated for the assessment. Special psoriasis area and severity index PASI) scores and dermatology life quality index (DLQI) scoring patterns were adopted for scrutinizing the symptomology. [Table 1] PASI is a quantitative rating score for measuring the severity of psoriatic lesions based on area coverage and plaque appearance. For assessment of the involvement of the body area, the rule of nine used to calculate the percentage of the burn was considered with certain modifications. The whole body was scored but, looking into the nature of the disease, the score was further specified to the organs.
Gradation for improvement
- Complete remission: 100%
- Markedly improved: In between 76% and 99%
- Moderately improved : In between 51% and 75%
- Mildly improved: In between 26% and 50%
- Unchanged: <25%.
The percentage of improvement in each parameter in both treated groups was calculated. The paired 't'test and the wilcoxon signed-rank test were used to assess the effect of therapy on subjective criteria in the individual group. The unpaired 't'test and coefficient of variation (CV) were applied to the statistical data for evaluating the differences in the effects of the two therapies in two ways: subjective and objective criteria. The overall effect of therapy on each scale was calculated with reference to the percentage improvement in all symptoms. Finally, the overall effect of therapy was evaluated by enumerating the number of patients in each improvement category.
| Results|| |
In the present clinical study, a total of 85 subjects were assessed for eligibility criteria. Among them, 76 subjects with Ekakushtha (psoriasis) were enumerated for management. From them, 73 subjects finished the full duration of treatment, while three patients left the treatment against medical advice at different stages. Two patients were shifted to another place, whereas one patient left the course of treatment for personal reasons. [Chart 1] Differnts signs and symptoms, involvement of body surface area and Nidana Sevena (causative factor) the subjects were showed in [Chart 2], [Chart 3], [Chart 4] respectively. Other observations in the patients were tabulated in the [Table 2].
[Table 3] shows highly significant (P < 0.001) difference between two groups in eosinophil count and MCV% whereas significant difference (P < 0.05) seen in monocytes. All other parameters of hematocrit show an nonsignificant difference (P > 0.05). [Table 4] shows a significant difference (P < 0.05) seen in FBS, S. triglycerides, and S. calcium. All other parameters of biochemistry show an nonsignificant difference (P > 0.05). All changes were within normal biological ranges in the combination of two therapies.
A comparison of the effect of treatment within the same group (paired 't' test) showed that both groups exhibited highly significant (P < 0.001) improvement in the chief complaints of Ekakushutha in the patients. There was a statistically significant difference (unpaired 't' test) (P > 0.05) in the effect of treatment between two groups on the parameters Daha and Kandu in the chief complaints. The CSHRM along with the GG-treated group was seen to provide better results in percentage change on Unnati, Kandu, Vaivarnya, the candle grease sign, the Auspitz sign, PASI, and DLQI scores. KSHRM along with the GG-treated group showed better results on Matsyasakalopamam, Aswedanam, Daha, Strava, and Mahavastu. [Table 5]
At the end of the treatment duration, the PASI score of all the subjects was calculated, and subjects were divided as per chronicity. There was a statistically significant (P < 0.05) and highly significant (P < 0.001) reduction in score noted in chronicity <1 year and chronicity >1 year to 10 year respectively in both the groups. There was better result found in CSHRM with GG treated group (88.46%, P < 0.01) in all patients who completed the treatment. It was also discovered that there was no statistically significant difference in the reduction of PASI score among subgroups of patients with varying chronicity.Patients with higher chronicity (6-10 years) have similar results (reduction of PASI score) as patients with 1 year chronicity and chronicity 1 to 5 years.This suggests that patients with more chronic disease who are resistant to treatment and have poor clinical outcomes in the later stages of the disease are frequently associated with complications such as psoriatic arthritis, etc.Hence, a similar improvement and reduction in PASI score in patients with a higher chronicity of 6–10 years is of great clinical significance. [Table 6]
|Table 6: Compression of PASI score as per isolated chronicity of the diseases statistically (effect before treatment and after treatment)*|
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A comparison of the effect of treatment on PASI score before the treatment and after the follow-up period with varying chronicity suggests that there was no significant reduction in the observed effect of drug treatment (which was achieved after 2 months of treatment) on PASI score after the follow-up period (even after the discontinuation of drug treatment for 1 month). The decrease in PASI score observed after follow-up in all patients with varying chronicity did not show many variations within them (as chronicity changed). PASI score reductions after follow up period were greater in the group treated with KSHRM “(79.08%, P < 0.001)” along with GG than in the CSHRM along with GG receiving group. Even in patients with chronicity of 6-10 years, the persistence of effect at the end of follow-up was clinically more significant, as the prognosis of psoriasis worsens with chronicity, along with the evolution and progression of chronicity and a reduction in the positive response to therapy. [Table 7]
|Table 7: Compression PASI score as per isolated chronicity of the diseases statistically (effect before treatment and end of follow up of 1 month)*|
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On applying a CV, CSHRM along with GG showed better and more consistent results except in the symptoms, i.e., Matsyaskalopamam, Aswedanam, and Strava. The major difference was found in the Daha symptom (CV of group A: 38.99, CV of group B: 58.29). [Table 8] In the overall effect of therapy, CSHRM along with GG group has shown better results than group B. These data are mentioned in [Chart 5].
|Table 8: Comparison of results on cardinal symptoms between the groups by applying coefficient of variation|
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| Discussion|| |
In this clinical trial, the maximum number of patients (i.e., 27.63%) with psoriasis were found in the age group of 50–60 years; this showed that the disease can occur at any stage of life. One study reported that the onset of psoriasis was bimodal, with two peaks of the disease: the first between 16 and 22 years of age and the second between 57 and 60 years of age. As the sample size was too small in the present study to draw any concrete conclusion, one cannot say that the disease is more prevalent at an older age. The maximum number of patients, i.e., 31.58%, were housewives. The course of psoriasis is inconsistent or inpredicatable, and the variations are numerous. In the present study 88.15% patients having gradual onset of disease. Ekakushtha is a disease characterised by Vata-Kapha dominance. As a result, the disease's progression may have been gradual. The most common type of psoriasis found in patients is plaque psoriasis. In the present study, 73.68% patients found that most common type and this support the same statement.
Psoriasis is a life-long disorder subject to unpredictable remissions and relapses. Single episodes are uncommon, and in them, there is frequent variety. An episode in the teenage years is followed by a series of attacks, each lasting a week or months, in the succeeding years. It is clear from the data of the chronicity-wise distribution of Ekakushtha patients that the maximum number of patients, i.e., 90.78%, had a chronic disease (>1 year), and 9.22% of patients were suffering from an acute disease (1 year). 48.68% of patients had a duration of 1–5 years, while 44.74% had a duration of 5–10 years. Acharya Charaka has considered Kushtha a chronic skin disease.
Patients, i.e., 43.42%, reported sunlight and dust as aggravating factors. 63.16 percent of patients had symptom aggravation during the winter season. In some studies, it is reported that the patients' skin lesions worsened during the winter., Studies have also indicated that cold weather may be a predisposing factor or trigger for psoriasis, in contrast to the hot and sunny climate that appears to be beneficial. Sheeta and Ruksha Guna are aggravated by the cold, and it may cause aggravation of Vata Dosha and disease in the winter season. 43.42% of patients were taking allopathic and ayurvedic medications simultaneously; this suggests a major trend in the choice of treatment line in this local area.
The dominance of Rasa (taste) in the diet of the patients was in the order of Katu (pungent -88.16%) > Amla (sour - 64.47%) > Madhura (sweet - 47.37%) > Lavana (salt -39.47%) > Kashaya (astrigent -7.89%) > Tikta (bitter - 03.95%). As per the classical text of Ayurveda, an excessive proportion of Katu Rasa in the diet causes an increase in Vata Dosha, Amla Rasa causes vitiation of Rakta Dosha, Madhura Rasa causes Shleshma Roga, and Lavana Rasa causes versatility for Kushtha. 40.78% of patients were practising Vishamashana (food irregularity) and Adhyashana (eating excess food). Vishamashana causes Vata Prakopa and the aggravation of disease conditions.
75.00% of patients were taking milk and Lavana (salt taste), while 53.95% of patients were taking milk and Krushara (thick gruel) together. Viruddha Aahara (incompatible food) may aggravate the symptoms of the disease due to the increased involvement of vitiated Dosha. Undigested food produces free radicals, as they can damage skin tissue and decrease the body's production of cyclic AMP. Research shows that 60% of people with psoriasis also have disorders of carbohydrate metabolism. Toxic substances produced by faulty digestion include polyamines, which prevent the body from making cyclic adenosine monophosphate [AMP], a regulator of metabolism in the cells. Viruddha Ahara can be considered Nidana (causative factor) only when a patient has a history of regular consumption for a longer duration and it causes the Nindita Vyadhis like Kushtha and Shwitra (leucoderma).
67.10% of patients had a history of Diwaswapa, which is a cause of Pitta and Kapha Dosha vitiation and also cause for Kotha (wheal like skin eruptions) & Kandu (itching) like skin disorders. The most common sites affected by the lesion of psoriasis reported by the patients were the hands (64.47%), legs (43.42%), the whole body (30.26%), the back (19.74%), and the face and trunk (18.42% each). These findings are also supported by modern medical texts. Prediction sites are the extensor surfaces (especially elbows and knees), trunk, and scalp. One study reported that approximately 20% of patients with plaque psoriasis present with the facial manifestations of the disease. Facial psoriasis is more frequently observed in patients with a longer disease duration, a family history of psoriasis, and more severe psoriasis. The face seems to be a less affected area. It is still not established whether this is due to the effect of sunlight or whether the facial skin itself is less susceptible to psoriasis. A maximum of 57.89% of patients had symmetrical patterns. Normally, the site of psoriasis is bilateral, often symmetrical. A well-demarcated border is an important feature for diagnosis in flexures and glans, where other features like scaling may be absent.
The persistence of the treatment's effect even after a one-month follow-up period suggests that the action of drugs is more than just an instant and or fast acting action or instant symptomatic relief in nature, such as instant anti-inflammatory, anti-allergic, antihistaminic, and photosensitizer (improving UV A absorption), but it may also have a long-term effect, such as long-term immunomodulation, persistent anti-inflammatory action, and because arsenicals are both local and systemic photosensitizers, and they have a significantly prolonged half-life in biological systems, their lipophilicity results in target deposition in fats, subcutaneous fat, whose excretion may be from hair follicles, hair openings, sebaceous secretions, and so on, affecting the dermal layers where the rate of proliferation is increased, which is one of the key pathological events of psoriasis. Lipophilicity with a long half-life and subcutaneous deposition increase and prolong photosensitivity, UV-A absorption, local and systemic immune suppression, and so on [Chart 6].
Vata and Pitta Doshas Sthana is Twak (skin). Ekakushtha has predominant features of scaling, dryness, cracks (the Auspitz sign), and impairment of the skin, suggesting the predominant involvement of Vata Dosha where there are complications such as the ageing of the skin, hyperpigmentation and or hypopigmentation, skin sensitization, and chronic inflammation. By default, the generalised treatment of Vata Dosha is the application and administration of Taila, or Sneha. Arsenicals, owing to their lipophilicity, have a tendency to get deposited in subcutaneous fat along with bone (marrow, fats), the brain, the nerves and, of course, the kidneys and liver as major sites of deposition. Skin appendages (skin, hair and nails) are among the excretory pathways of arsenicals; hence, they may be a judicious choice in treating dermal affections like psoriasis. Although Kushtha is a chronic skin disease, its chronicity and prognosis are most often evident in the case of Ekakushtha, as advocated by Acharya Charaka to add Rasayana therapy to all chronic diseases. The drugs that are to be given for prolonged periods of time, often for a long time, especially in cases of psoriasis in the paediatric age group, must be safer. However, the results can be revalidated by a well-designed clinical trial with a larger sample size.
Adverse Drug Reaction
No adverse drug reactions were observed in any of the patients.
| Conclusion|| |
In the present study, statistically highly significant (P < 0.001) results were found in both the groups on the cardinal symptoms of Ekakushtha and parameters of assessment (PASI score and DLQI) after treatment, and there was the persistence of the effect of treatment on PASI score in both the groups with an insignificant reduction even till the end of the follow-up of one month without any medicine. Rasamanikya prepared with both the media Shodhita Haratala and Guduchi Ghana were discovered to be safe and effective psoriasis treatments.
The author would like to thank Dr. Swpnil Chaudhari, for their guidance to prepare this manuscript. The author would like to thank Dr. Sarika Makwana, and Dr. Om Pandey for helping throughout the study.
Financial support and sponsorship
Institute for teaching and research in Ayurved., Jamanagar.
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7], [Table 8]