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ORIGINAL ARTICLE
Year : 2021  |  Volume : 42  |  Issue : 1  |  Page : 30-34  

Efficacy of Vamana Karma (therapeutic emesis) followed by Darvyadi Kwatha (herbal decoction) in the management of prediabetes (Prameha) - A single-arm clinical trial


Department of Panchakarma, All India Institute of Ayurveda, New Delhi, India

Date of Submission08-Nov-2020
Date of Decision28-May-2021
Date of Acceptance19-Sep-2022
Date of Web Publication07-Dec-2022

Correspondence Address:
Santosh Kumar Bhatted
Department of Panchakarma, All India Institute of Ayurveda, Sarita Vihar, New Delhi 110076
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ayu.ayu_417_20

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   Abstract 


Background: Prediabetes is an alarming condition to control and prevent from developing diabetes mellitus which occurs due to the change in lifestyle and food habits. Timely untreated prediabetes turn into type-2 diabetes mellitus within a year and systemic complications such as retinopathy, nephropathy, and neuropathy could occur and in later stage multi system damage could take place. Aims: The ai of this study is to evaluate the efficacy of Vamana Karma (therapeutic emesis) with Ikshuvaku Yoga and followed by oral administration of Darvyadi Kwatha (herbal decoction) in the management of prediabetes. Materials and methods: After approval of IEC and registration under clinical trial registry of India, 20 patients suffering from prediabetes were registered in the trial. Diagnosis criteria were hemoglobin A1c (HBA1c), fasting blood sugar (FBS) and postprandial blood sugar (PPBS), and assessment criteria includes HBA1c, FBS, PPBS, along with improvement in Agnibala (strength of digestion and metabolism), Dehabala (physical strength) and Satvabala (mental strength), relief sign and symptom of prediabetes (Prameha), and improvement in quality of life (SF-36 Score). Classical Vamana Karma followed by oral administration of Darvyadi Kwatha was done. Total duration of treatment was 45 days and last follow-up was done on the 120th day. Student's t– test was used for the analysis of parametric data. Results: After the treatment were observed that there is improvement in subjective as well as in objective parameters. Statistically highly significant result was observed in HBA1c (BT [day 0] Mean score 6.25 and AT [day 120] 5.63 [P < 0.001]), FBS (BT [day 0] mean score 120.05 and AT [day 120] 93.31 [P < 0.001]) and PPBS (BT [day 0] mean score 165.26 and AT [day 120] 112.84 [P < 0.001]), sign and symptoms of Prameha, Dehabala, Agnibala, Satvabala, and quality of life (SF-36 Score). Conclusion: The present clinical study concludes that therapeutic emesis (bio purification) followed by Darvyadi Kwatha as internal medicine shows significant result in treating prediabetes (Prameha) safely and effectively also control and prevent developing diabetes mellitus. None of the patient converted to diabetes mellitus on the day 120.

Keywords: Darvyadi Kwatha, Prameha, prediabetes, Vamana Karma


How to cite this article:
Yadav U, Bhatted SK. Efficacy of Vamana Karma (therapeutic emesis) followed by Darvyadi Kwatha (herbal decoction) in the management of prediabetes (Prameha) - A single-arm clinical trial. AYU 2021;42:30-4

How to cite this URL:
Yadav U, Bhatted SK. Efficacy of Vamana Karma (therapeutic emesis) followed by Darvyadi Kwatha (herbal decoction) in the management of prediabetes (Prameha) - A single-arm clinical trial. AYU [serial online] 2021 [cited 2023 Jan 31];42:30-4. Available from: https://www.ayujournal.org/text.asp?2021/42/1/30/362931




   Introduction Top


Prediabetes as a state of intermediate hyperglycemia using three specific parameters, fasting blood sugar (FBS) level 100–125 mg/dl, postprandial blood sugar level between 140 and 200 mg/dl and hemoglobin A1c (HbA1c) level of 5.7% to 6.4% for the definition of prediabetes.[1] The WHO estimates that diabetes was the seventh leading cause of death in 2016. The global diabetes prevalence in 2019 was estimated to be 9.3% (463 million people), rising to 10.2% (578 million) by 2030 and 10.9% (700 million) by 2045.[2] Prediabetes is the metabolic disorder can be compared with Prameha based on the clinical signs and symptoms of prediabetes it has a close resemblance to the disease Prameha described in Ayurveda.[3] A clinical condition characterized by excessive turbid urination is broadly termed as Prameha, which is further classified into twenty subtypes based on the involvement of Dosha and presentation of urine, all the Prameha in due course of time converts into Madhumeha (diabetes mellitus). The management of type-2 diabetes mellitus (T2DM) includes oral hypoglycemic drugs and insulin in the later stage. On one side, condition deteriorates due to side effects of medication and on another side due to complications of T2DM itself. The entire globe is searching for safe and effective treatment for preventing and controlling T2DM. Prameha is a disease caused due to Mandagni (~low digestive fire and metabolism), Bahudosha (excessive Dosha), Bahudravashleshma (Kapha with increase liquidity), and Abaddhameda (increased triglyceride and bad cholesterol) along with an increase of Kleda (excessive fluidity) in the body, all of which belongs to the group of Kapha substance in the body.[4] Hence, Samshodhana (Vamana)[5] treatment is one of the best remedies for correcting Agni (digestive fire)[6] and elimination of Bahudosha. Further Vamanakarma is the best treatment specifically for the elimination of excessive Kapha and related substances like Kleda and to reduce Abaddhameda from the body. Darvyadi Kwatha, especially indicated in all kinds of diabetes by Acharya Charaka.[7] Hence, Vamana Karma[8] followed by oral administration of Darvyadi Kwatha was selected for the treatment of prediabetes.

[TAG:2]Materials and methods [/TAG:2]

Ethics

After getting approval from the Ethics Committee (AIIA/2018/PG-73), the trial was registered in central trial registry –India (CTRI/2019/03/017952), it was registered prospectively. Informed consent was obtained from all enrolled individuals on clinical trial.

Participants

After screening 39 patients, 20 patients were enrolled for schedule of 15 days classical Vamana Karma with Ikshvaku Yoga[9] followed by the oral administration of Darvyadi Kwatha in the dose of 80 ml twice a day before food for 1 month.

Inclusion criteria

Age between 30 years and 60 years, obese patients, HBA1C between 5.7% and 6.4%, FBS level between 100 and 125 mg/dl and body mass index >25.

Exclusion criteria

Insulin-dependent diabetes mellitus patients, gestational diabetes, patients on steroids or oral hypoglycemic drugs, malignant and accelerated hypertension, CCF, pregnant women, and lactating mother suffering with any serious disease condition.

Diagnostic criteria

Thirty-eight patients screened and 20 patients were registered for the study. HBA1C between 5.7% and 6.4%, fasting plasma glucose 100 mg/dl–125 mg/dl, and postprandial blood glucose 140 mg/dl–200 mg/dl.

Intervention

Vamana Karma was planned for patients on inpatient department basis. Deepana (appetizers) and Pachana (carminatives)[10] were started with Nagarmotha Churna (Cyperus Rotundus L.)[11] 3 g twice a day before food and Panchakola Churna (Pippali [Piper Longum L.], Pippalimoola [Root of Piper longum L.], Chavya [Piper Retrofrectum Vahl.], Chitraka [Plumbago Zeylanica L.] and Shunthi [Zingiber Officinale Roscoe.])[12] Three gram twice a day after food for 3 days. Then, Snehapana (internal oleation)[13] was done with Murchhita Ghrita (a medicated ghee)[14] for 5 days in increasing dose. After that Sarvanga Abhyanga (external oleation)[15] and Vashpa Swedana (whole body steam)[16] were done with Tila Taila (sesame oil) and Dashmoola Kwatha (decoction of ten roots), respectively, for 2 days. Vamana Karma was done with classical Ikshvaku Yoga (Madhuyashti Kashaya Yoga). On the day of Vamana Karma, patients after confirming digestion of previously taken food, vitals were measured and given Akanthpana with Ksheer (milk). Then Vamaka drugs were given with Ikshvaku Yoga and waited for one Muhurta (48 min). If within one Muhurta Vamana is started, then it was continued with Madhuyashti Phanta[17] until Pittanta Darshana as per strength of the patient. After that Lavnodaka was given until Samyaka Lakshana (appropriate symptoms) of Vamana Karma were observed and vitals were measured frequently.[18] Samsarjana Karma (special dietetic regimen) was given for 5 days, followed by the oral administration of Darvyadi Kwatha 80 ml twice a day before food to the patients for 30 days [Table 1].
Table 1: Proposed therapeutic procedures, drugs doses, and time schedule

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Assessment criteria

Objective criteria includes HBA1c, FBS and postprandial blood sugar (PPBS) and subjective criteria includes sign and symptoms of Prameha, Agnibala (strength of digestion and metabolism), Dehabala (physical strength) and Satvabala (mental strength)[19] and quality of life by SF36 score details mentioned in table [Table 2] and [Table 3].
Table 2: Assessment criteria of sign and symptoms of Prameha

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Table 3: Assessment criteria of Agnibala (~strength of digestion and metabolism), Dehabala (physical strength) and Satvabala (mental strength)

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Outcome

A total of 20 patients of prediabetes were registered, of which 19 patients have completed the course with follow-up and one patient discontinued the treatment due to the emergency condition occurred in home. The observation of the study shows that majority of the patients were belonging to age group of 40–49 years. Agni (digestive power) wise distribution shows that maximum patients were Vishmagni (disturbed digestion) and Mandagni (low or lack of digestive fire and metabolism).[6] Majority of patients were Pitta-kapha and Vata-Kapha Prakriti (constitution).[20]

Primary end point result showed statistically highly significant in HBA1c (MEAN + standard deviation [SD] BT 6.25 + 0.21 and AT 5.63 + 0.36) and secondary end point results showed also highly significant improvement in FBS (MEAN + SD BT 120.05 + 10.4 and AT 93.31 + 6.9), PPBS (MEAN + SD BT 165.26 + 16.1and AT 112.84 + 10.9), Agnibala (strength of digestion and metabolism), Dehabala (physical strength) and Satvabala (mental strength) and overall improvement in quality of life (SF-36 Score) [Table 4] and [Table 5]. Assessment was done for HBA1c on 120th day and other parameters on 46th, 76th, 107th, and 120th day.
Table 4: Effect of intervention on objective parameters

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Table 5: Effect of intervention on subjective parameters

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   Results Top


All the objective parameters (BT [day 0] mean score 6.25 and AT [day 120] 5.63 [P < 0.001]), FBS (BT [day 0] mean score 120.05 and AT [day 120] 93.31 [P < 0.001]) and PPBS (BT [day 0] mean score 165.26 and AT [day 120] 112.84 [P < 0.001]) have shown statistically highly significant results. Improvement in Agnibala (~strength of digestion and metabolism), Dehabala (physical strength), and Satvabala (mental strength) and quality of life (SF-36 score) were also statistically highly significant [Table 4], [Table 5], [Table 6].
Table 6: Effect of intervention on SF-36 score

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   Discussion Top


Results on all the parameters, were significant particularly HBA1c (<0.001), FBS (<0.001) PPBS (<0.001), Agnibala (<0.001), Dehabala (<0.001), Satvabala (<0.001), and quality of life (SF-36 Score) parameters were shown statistically highly significant results. Prediabetes occur due to change in food habits, irregular sleep pattern, and mental stress or anxiety leads to unbalancing of biological system of the body or in other word in disturbed threshold of the digestion capacity in the intestine and further leads to imbalance in functional capacity of other system of the body, and gradually imbalance in anatomical structure of the body as well. Metabolic disorder is nothing but imbalance threshold of digestion capacity of the intestine and prediabetes is also one among the metabolic disorders. Pathogenesis of prediabetes starts with Mandagni in general and slow Medodhatvagni (metabolism of fatty acids) in particular due to which not able to convert glucose into glycogen; hence, blood sugar levels increase in the blood. Apart from this research shown main causative factor is disturbed sleep pattern in reference to biological clock of the patients of prediabetes. In prediabetes patients, Mandagni may occur on three, two or one levels such as Jathragni (digestive fire), Dhatvagni (metabolic function), and Bhutagni (neurotransmitters and receptors).[6]

Vamana Karma is considered as the best treatment for the elimination of Kapha Dosha and related body constituents it also reduces, Kleda (excessive Dravadhatu), Abaddhameda (increased lipids) which are the major culprits in prediabetes. Lagenaria siceraria Linn (bottle gourd [Ikshvaku]) was used for Vamana karma. It has been indicated in diabetes, hypertension, Kasa (asthma), Shwasa (chronic obstructive pulmonary disease), Jwara (fever), Gulma (specific pain in abdomen), Udara Roga (ascites), Granthiganda (benign tumors and cysts), Pandu (anemia and cardiac diseases), Kushtha (psoriasis), Shleepada (filariasis) and Visha (poisoning).[21] It acts due to hot (Ushna), intense (Teekshna), subtle (Sukshma), pervasiveness (Vyavayi) and a substance which first gets dispersed throughout the body and then undergoes transformation (Vikashi) property and study shows vomiting (Urdhvabhagaprabhavata) effect due to presence of cucurbitacins and its pharmacodynamics action.[22] Darvyadi Kwatha has shown anti-diabetic action it acts on gastrointestinal tract which increases the Agni due to ingredient like Nagarmotha which has easily digestible (Laghu), dry (Ruksha Guna) and bitter taste (Tikta Rasa), cleansing of GIT due to ingredients like Haritaki, Bibhitaki and Amalki which has laxative and reduces Kleda of the body due to ingredients of Triphala, Devdaru, Daruharidra and Nagarmotha which has Ruksha, Laghu Guna action and Kashaya, Tikta Rasa property.[23]


   Conclusion Top


Prediabetes commonly affects the middle-aged people living a sedentary life. Positive family history plays a major role in its development. In the early course of disease, Samshodhana (bio purification) must be the choice of treatment as, at this stage patient has dominance of Kapha-Pitta Dosha. Statistically highly significant results were found, the percent decline in mean of HBA1c (9.9), FBS (22.2) PPBS (31.7), Agnibala (Ruchi (75.8) and Vaata Mutra Purisha Retasam Mukti (79.3)), Dehabala (84) and Satvabala (Nidra Labho Yathakalam (85.8) and Sukhena-Cha – Pratibodhanam (76.6)). This study suggests that Vamana Karma followed by the oral use of Darvyadi Kwatha in the dose of 80 ml in the morning and evening before food can effectively treat prediabetes and prevent landing in diabetes mellitus. No adverse effects were observed during the complete research work.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
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    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]



 

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