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| CLINICAL RESEARCH |
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| Year : 2014 | Volume
: 35
| Issue : 2 | Page : 152-159 |
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A comparative clinical study of Asanadi Ghanavati and Gomutra Haritaki in Kapha Medo Margavarana (dyslipidemia)
Shivam G Joshi1, Hari Mohan Chandola2, Alankruta R Dave1
1 Department of Kaya Chikitsa, Institute for Post Graduate Teaching and Research in Ayurveda, Gujarat Ayurved University, Jamnagar, Gujarat, India
2 Ch. Brahm Prakash Charak Ayurved Sansthana, Khera Dabar, New Delhi, India
| Date of Web Publication | 5-Dec-2014 |
Correspondence Address:
Shivam G Joshi
Ph.D. Scholar, Department of Kaya Chikitsa, I.P.G.T. and R.A., Gujarat Ayurved University, Jamnagar - 361 008, Gujarat
India
 Source of Support: None, Conflict of Interest: None  | Check |
DOI: 10.4103/0974-8520.146231
 Abstract | | |
Background: Dyslipidemia is a disorder of lipoprotein metabolism, including lipoprotein overproduction or deficiency and it can be understood in the parlance of the closest conditions in Ayurveda, viz. Kapha Medo Margavarana (dyslipidemia), Atisthaulya (obesity) or Meda Roga and Prameha. Asanadi Ghanavati (AG) is a modified presentation of Asanadi Gana drugs referred in Ashtanga Hridaya and Gomutra Haritaki (GH) is described in Charaka Samhita under Shotha Chikitsa and Ashtanga Hridaya in Arsha Chikitsa. Aim: To evaluate and compare the clinical effect of AG and GH in Kapha Medo Margavarana. Materials and Methods: Patients with the high lipid profile were selected and randomly divided into two groups. In Group A (n = 30), patients were administered with tablet of AG 1 g (500 mg each) thrice a day for 8 weeks and in Group B (n = 30), tablet of GH in similar dose and duration. Effect of therapy was assessed by body circumference, Body Mass Index (BMI), cardinal symptoms like Anga-Gaurava, Bharavriddhi, etc., and lipid profile parameters. Result: AG decreased the serum cholesterol by 7.12%, Serum Triglyceride (S. TG) by 7.72%, Serum Low Density Lipoprotein (S. LDL) by 11.68%, Serum Very Low Density Lipoprotein (S. VLDL) by 7.73%, and had increased Serum High Density Lipoprotein (S. HDL) by 9.52%, with moderate improvement in 14.81% and mild improvement in 70.37% of patients. The GH decreased the serum cholesterol by 6.31%, S. TG by 9.61%, S. LDL by 12.55%, serum VLDL by 8.99%, and increased S. HDL by 10.52% with moderate improvement in 3.70%, and mild improvement in 74.07% patients. Conclusion: AG and GH are suggested to be used in Kleda Bahul Samprapti Janya Vyadhi and Ama Bahul Samprapti Janya Vyadhi respectively. Keywords: Asanadi Ghanavati , dyslipidemia, Gomutra Haritaki, Kapha Medo Margavarana
How to cite this article:
Joshi SG, Chandola HM, Dave AR. A comparative clinical study of Asanadi Ghanavati and Gomutra Haritaki in Kapha Medo Margavarana (dyslipidemia). AYU 2014;35:152-9 |
How to cite this URL:
Joshi SG, Chandola HM, Dave AR. A comparative clinical study of Asanadi Ghanavati and Gomutra Haritaki in Kapha Medo Margavarana (dyslipidemia). AYU [serial online] 2014 [cited 2023 Jun 6];35:152-9. Available from: https://www.ayujournal.org/text.asp?2014/35/2/152/146231 |
| Introduction | |  |
In the modern era, sedentary life-style and drastic changes in food pattern may lead to diseases such as dyslipidemia, type-II Diabetes Mellitus (DM), hypertension, and obesity, which are closely linked with each other and often co-exist in individual making the syndrome more complex and difficult to manage. Dyslipidemia stands as the most firmly established and the modifiable risk factor for cardio- and cerebro-vascular accidents, due to the presence of abnormal level of cholesterol, which is a causative factor for atherosclerosis. According to National Commission on Macroeconomics and Health, there would be around 62 million patients with the Coronary Artery Disease (CAD) by 2015 in India and of these 23 million would be patients younger than 40 years of age. [1] The four leading causes of death globally in 2030 are projected to be ischemic heart disease, cerebro-vascular disease (stroke), HIV/AIDS, and chronic obstructive pulmonary disease. [2] CAD is usually due to atherosclerosis of large and medium sized arteries, and dyslipidemia has been found to be one of the most significant contributing factors. In Ayurveda, various attempts have been made to use distinctive nomenclature to denote the word dyslipidemia, viz. Rasagata Sneha Vriddhi, Rasa Raktagata Sneha Vriddhi, Medodosha, and Kapha Medo Margavarana.
Dyslipidemia can be taken as Kapha Medo Margavarana, which denotes Samprapti (pathologenesis) rather than a clinical diagnosis. Asanadi Ghanavati (AG) [Table 1] is a specific herbal formulation explained in Shodhanadi Gana Samgraha.0" [3] The drugs are indicated specially in the diseases in which Kapha Dosha and Medo Dushya are vitiated predominantly viz. Shwitra, Kushtha, Pandu, Prameha, Medoroga, etc., Most of the drugs have Ruksha (dry) Guna (property), Kashaya Rasa (astringent taste), Katu Vipaka, Lekhana as well as Chhedana Karma and are useful in Kapha Medo Margavarana Janya condition like dyslipidemia. Gomutra Haritaki (GH) is referred for Kaphaja Shotha Chikitsa.[4] Haritaki (Terminalia chebula Retz.) and Gomutra (cow urine) are the constituents of this formulation. AG and GH can be helpful to destruction the etiopathogenesis of the disease.
So this study was undertaken to evaluate and compare the clinical effect of AG and GH in patients suffering with the Kapha Medo Margavarana (dyslipidemia).
| Materials and Methods | | |
Study design
It was a randomized, parallel, and interventional clinical trial. Informed consent was taken from all the patients. Patients (n = 60) with the high lipid profile were selected during October 2011 to April 2012 from Outdoor Patient Department of Kaya Chikitsa, IPGT and RA, Jamnagar and were alternatively divided into two groups (Group A and B). The research protocol was approved by Institutional Ethics Committee (No. PGT/7-A/Ethics/2011-12/2087; dt. 05-09-2011) and registered in CTRI (No.: CTRI/2011/12/002281).
Inclusion criteria
- Patients with age 25 to 60 years
- Elevated levels of serum cholesterol (201 mg/dl or more) and/or elevated serum triglycerides (S. TGs) (151 mg/dl or more) and/or, elevated serum low density lipoprotein (S. LDL) (131 mg/dl or more) and/or elevated serum very low density lipoprotein (S. VLDL) (41 mg/dl or more). [5]
Exclusion criteria
- Patients suffering from type -I DM
- Drug induced dyslipidemia
- Patients with the serious systemic illness such as tuberculosis, carcinoma, and advanced stage of DM.
Investigation
Routine hematological examinations were carried out before and after treatment to rule out any pathological conditions. Bio-chemical test such as complete lipid profile, fasting blood sugar (FBS), serum creatinine, and the blood urea were carried out. Apo-lipoprotein B (Apo-B) as Bio-marker was investigated in 10 patients in each group.
Drugs and posology
Group A
Tablet of AG (500 mg each) was administered in dose of 2 tablets (1 g), thrice a day with Ushnodaka (luke warm water) before food for 8 weeks.
Gorup B
Tablet of GH was administered in the same dose and duration of group A.
Follow-up
Follow-up was carried out for 2 weeks after the completion of treatment to see the long-standing effect of the drug.
Pathya-Apathya
No specific diet or exercise pattern was advised during the study period. Subjects were only advised to avoid the excess usage of oils in the dietary articles.
Criteria for assessment of the total effect of therapy
The overall effect was assessed on the basis of relief in chief complaints (as subjective criteria) and lipid profile (objective criteria) such as decrease in the serum cholesterol, S. TG, S. LDL, S. VLDL and increase in serum high density lipoprotein (S. HDL).
The overall effect was assessed on following criteria:
- Complete remission - 100% relief
- Markedly improved - <100% to > 75% relief
- Moderately improved - 75% to > 50% relief
- Mild improvement - 50% to > 25% relief
- Unchanged - 25-0% relief.
Statistical analysis
The Wilcoxon signed rank test method was used to check the significance of the subjective criteria and paired t test was used for objective criteria in a single group. To compare the effect of therapy of two groups, Chi-square test was carried out for the subjective criteria and unpaired t test for objective criteria. The obtained results were interpreted as, insignificant P > 0.05, significant P < 0.01, highly significant P < 0.001
| Observations | | |
Out of 60 patients, the maximum (37%) belonged to age between 45 to 55 years. 50% and 60% patients were male in group A and B respectively. The majority of patients in group A (80%) and group B (70%) were Hindu. 96% of patients of group A and 83.33% of the patients in group B were married. It was observed that, 50% of the females in group A and 40% in group B were housewives in this study. Most of the patients in both groups belonged to middle and rich socio-economic status. In Nidanas, Ahara was found to be dominant in Madhura Rasa (91.33%), Snigdha Guna (70%), Guru Guna (65%), and Sheeta Veerya (63%). Vishamashana (68.33%) and Adhyashana (36.67%) were found most inappropriate. Maximum patients (90%) were habituated of regular consumption of oily, fried foods, bakery items, curd, etc. In Vihara, Divaswapa (85%), and Avyayama (68.33%) were found most common. In this study, 60% patients had reported of having affection with Ati-chinta (stress) and Krodha (anger). Most of the patients (71.67%) had gradual onset of disease and the disease was chronic for 1-5 years in 58.33% patients. DM-II and hypertension were observed in 16.67% and 15% patients of both groups. A total of 33.33% patients had a positive family history of dyslipidemia. The majority of patients showed symptoms of Angagaurava (76.67%), Bharavriddhi (71%), and Ayase-Shwasa (53.33%). Dushti of Kapha Dosha, Rasa Dhatu, Rakta Dhatu, and Medo Dhatu were observed in 78.33%, 88.33%, 30%, and 86.67% respectively. Dashavidha Pariksha revealed that 52% of the patients had Kaphapradhana Pittanubandhi Sharira Prakriti 67% had Tamasika Prakriti 90% were of Madhyama Sara, 70% were of Madhyama Satva, and 61.67% were of Madhyama Samhanana. The study revealed that, 81.67% of the patients had BMI greater than 25 and 70% had body weight between 70 kg and 100 kg.
| Results | | |
Effect of therapy on symptoms
In group A, there were relief of symptoms Angagaurava (85.37%), Ayase Swasa (92.91%), Bharavriddhi (6.02%), Atipipasa (50%), Atikshudha (66.65%), Daurbalya (81.81%), Sandhishool (57%), Alasya (55.09%), and Sphik-Stana-Udara Avalambana (47.40%). The relief in Angagaurava, Ayase Swasa, Alasya, Daurbalya, Sphik-Stana-Udara Avalambana was statistically highly significant (P < 0.001). Change of relief on Sandhishoola was statistically significant (P < 0.01). Statistically insignificant results were found in Atikshudha, Atipipasa and Bharavridhhi (P > 0.05) [Figure 1],[Figure 2].
In group B, relief of symptoms was observed in Angagaurava (90.08%), Ayase Swasa (87.97%), Bharavriddhi (7.05%), Atipipasa (75%), Atikshudha (73.33%), Daurbalya (66.67%), Sandhishool (73%), Alasya (49.70%), and Sphik-Stana-Udara Avalambana (35.61%). The relief in Angagaurava, Ayase Swasa, Atipipasa, Sandhishool, and Sphik-Stana-Udara Avalambana were statistically highly significant (P < 0.001). In Bharavridhhi, the relief was statistically significant (P < 0.01). Statistically insignificant results were found in Daurbalya, Alasya and Atikshudha (P > 0.05) [Figure 1].
Effect on body weight
Body weight was reduced by 2.53% of the subjects in group A, whereas BMI was reduced by 2.59%. In group B, body weight and BMI were reduced by 3.57% and 2.71% respectively. The changes were statistically highly significant (P < 0.001) in both the groups [Figure 2].
Effect on body circumference
In group A, circumference of chest, abdomen, hip, pelvis, mid-thigh, and calf were reduced by 0.79%, 1.69%, 1.66%, 0.93%, 2.47%, and 1.09% respectively. In group B, circumference of chest, abdomen, hip, pelvis, mid-thigh, and calf were reduced by 0.45%, 1.12%, 1.80%, 0.93%, 2.34%, and 1.76% respectively. The results were found statistically highly significant (P < 0.001) in both the groups [Figure 3].
Effect on skin folds thickness
In group A, skin fold thickness of biceps, triceps, and abdomen was reduced by 5.53%, 5.22%, and 4.64% respectively. In group B, skin fold thickness of biceps, triceps, and abdomen was reduced by 4.99%, 4.84%, and 5.05% respectively. The results were found statistically highly significant (P < 0.001) in both the groups [Figure 4].
Effect on lipid profile
On statistical evaluation S. cholesterol, S. TGs, S. LDL and S. VLDL were reduced by 7.12%, 7.72%, 11.68%, and 7.73% respectively, whereas S. HDL and apo-lipoprotein were increased by 9.52% and 11.78% respectively in group A. The results were statistically significant in S. cholesterol, S. LDL, S. HDL (P < 0.01) and insignificant in S. TG, S. VLDL and apo-lipoprotein (P > 0.05) [Table 2].
In group B, S. cholesterol, S. TGs, S. LDL, and S. VLDL were reduced by 6.31%, 9.61%, 12.55%, and 8.99% respectively, whereas S. HDL and apo-lipoprotein were increased by 10.52% and 1.89%. The results were statistically significant in S. cholesterol, S. LDL, S. HDL (P < 0.01) and insignificant in S. TGs, S. VLDL and apo-lipoprotein (P > 0.05) [Table 3].
Effect on bio-chemical parameters
In group A, 9.65% reduction was observed in FBS level, 5.15% decrease in S. creatinine, 0.97% increase in S. urea which is Within Normal Limit (WNL), although in group B 0.22% increase in FBS level (which is WNL), 1.0% decrease in S. creatinine, and 10.91% decrease in S. urea.
Comparison between both the groups
On comparison of both Groups, the un-paired t test showed insignificant difference in the objective parameters [Table 4]. While comparing the effect of therapy over the subjective criteria by using Chi-square analysis, both the groups showed similar effect as the results were insignificant [Table 5].
Overall effect of therapy
In group A, 27 patients had completed the course of treatment. Out of them moderate improvement was observed in 4 (14.81%) patients, mild improvement was observed in 19 (70.37%) patients, whereas no improvement was observed in 4 (14.81%) patients.
In group B, 27 patients had completed the course of treatment; out of them moderate improvement was observed in 1 (3.70%) patient, mild improvement was observed in 20 (74.07%) patients, whereas no improvement was observed in 6 (22.22%) patients.
| Discussion | | |
The term Margavarana signifies the obstruction in the channels; in this study Margavarana refers to obstruction in Raktamarga rather than other channels within the body. S. cholesterol in patients of groups A and B were decreased by 7.12% and 6.31% respectively, which was statistically significant (P < 0.05). S. cholesterol is the total level of cholesterol that is found in the blood stream. Moreover, it helps to have a rough idea regarding the balance between the HDL and LDL cholesterol. Hence, the reduction in cholesterol levels that is significant has to be considered as a positive outcome of the trial drugs. On S. TG both drugs showed a decrease by 7.72% and 9.29% respectively, which was statistically insignificant. When absorption of triglyceride in the intestine is proper, it may reduce S. TG level. Over production of VLDL and triglyceride in the liver has been proposed to be driven by high levels of Serum free fatty acid in patients with insulin resistance. [6] The ingredients of AG and GH are hepato-protective and anti-hypercholesterolemic. Hence, it can be understood that the action of drug is mainly on the endogenous/hepatic pathway of lipids. Both drugs showed S. VLDL decrease by 7.73% and 8.99% with a mean difference of 16.54 and 11.76 respectively, but it was statistically insignificant. VLDL contains the highest amount of TGs, and it is also considered as bad cholesterol as it helps cholesterol build up on walls of arteries. Hence, drop in the mean VLDL value attained in working groups is supporting the lipid lowering efficacy of AG and GH.
On S. LDL both drugs showed a decrease by 11.68% and 12.55% respectively, which was statistically significant. In the present study, mean cholesterol level was decreased, and mean HDL level was increased, which directly indicates the reduction of LDL level. The probable mechanism may be that the trial drugs reduce intestinal absorption of cholesterol by reducing the LDL particle concentrations. In AG; Asana (Pterocarpus marsupium Roxb.), Arjuna (Terminalia arjuna W. and A.), Shirisha, Rakta-Chandana (Pterocapus santalinus Linn.f.), Shaka (Tectona grandis Linn.); and in GH, both Gomutra[7] and Haritaki[8] may have anti-oxidant activity. Both drugs may reduce oxidative stress by preventing lipid peroxidation with more than two double bonds (free radicals). In both groups, S. HDL was increased by 9.52% and 10.52% respectively, which was statistically significant. HDL is considered as good cholesterol because of its effectiveness in cholesterol removal from the periphery to liver (reverse cholesterol transport). Drugs probably inhibit an enzyme in the liver that is involved in triglyceride synthesis, causing a decrease in VLDL production. It in turn leads to reduction in free fatty acids in the visceral fat levels, and thereby improvement in the HDL levels.
Apo-B 100 is the primary apo-lipoprotein of the LDL which is responsible for carrying cholesterol to the tissues. The normal level is considered as 40-125 mg/dl. In the present study, both groups showed an increase in Apo-B level but were within normal limits. In AG group, FBS was reduced by 9.55% although in GH group, FBS was increased by 0.22%, but it is within normal limit. Ingredients of AG such as Asana, Karanja (Pongamia glabra Vent), Khadira (Acacia catechu Willed), Mesha-sringi (Gymnema Sylvester R.Br), Daruharidra (Berberis aristata DC.), Shaka, and Kalinga are established hypoglycemic drugs. This study proves that, AG is an ideal drug which can lower the BSL (in pre-diabetics and diabetics).
AG and GH both showed improvement on Angagaurava, which was decreased by 85.36% and 90.08% respectively. Guru Guna, which is mainly responsible for Angagaurava is also a causative factor for increasing Ama resulting in formation of Pralepa in Rasavaha and Raktavaha Srotasa. Tikshna, Ushna, and Ruksha Guna of GH help to subside Gaurava by clearing Sroto-avarodha. AG showed improvement on Daurbalya, which was decreased by 81.81%, which is mainly due to Sroto-Avarodha, which ultimately hampers the nutrition of next Dhatu. AG decreases Kleda as well as Sroto-Avarodha. Atikshudha and Atipipasa are due to Tikshnata of Pachakagni and increased Vata in Koshtha Sthana.[9] GH increase Jatharagni by Amapachana. It clears Sroto-avarodha and Medomargavarana. Ultimately, Prakruta Gati of Vata leads to Samyaka Kshudha and Pipasa. Sandhishoola is due to Bharavridhhi (Rasagata Sama Shleshma) or Samata (Medogata Sama Sleshma). Amapachana property of GH decreases Sandhishoola by converting Sama condition into Nirama. Tikta, Kashaya, Sheeta, Pitta-Kaphahara property of AG decrease Kleda and Meda as well as it reduces Swedadhikya and Daurgandhya. Alasya is due to Hetu like Guru, Snigdha, Madhura Ahara, which produce Ama, Kleda, Abhishyanda, Sroto-Avarodha. AG has Laghu, Ruksha and Tikta-Kashaya property. It helps in Kleda Upashoshana, decreases Abhishyanda, Sroto-Avarodha and Alasya. Ayase Swasa is one of the symptoms of Medo Vridhhi. Reduction in Apachita Medovriddhi (Medakshaya) showed improvement on the symptoms like Ayase Swasa. Nidradhikyata (Tamo Sleshma Samudbhava) is either due to Sroto-avarodha or Manasa Tamo Adhikya (Manovaha Srotasa).
Probable mode of action of AG
Due to Kleda Dustikara Nidana, it increases Kleda, Sleshma, and Snehamsha in Rasa, Rakta, and Medo Dhatu. Guru and Snigdha Guna manifest symptoms such as Medovridhhi, Sphik-Stana-Udara Avalambana, Ayase Swasa, Daurbalya, Daurgandhya, Swedadhikya result in Kleda Bahula Samprapti Janya Vyadhi such as Prameha, Kustha, and Meda-roga. AG has Laghu, Ruksha, Sheeta, Tikta, Kashaya, and Katu Vipaka. Tikta, Kashaya and Sheeta having action of Kleda, Medo, Vasa, Mutra, Sweda Shoshana, Shodhana and Rakta Prasadana, which decrease Raktagata Kleda and Meda. Ultimately reduce Medoshaithilya. AG probably works at the level of Medodhatwagni. Ingredients of AG, Asana[10] having action of anti-hyperlipidemic, anti-diabetic, cardiac tonic; Tinisha (Ougeinia dalbergioldes Benth.) [11] having anti-inflammatory, cancer preventive, hypocholesterolemic; Arjuna[12] having cardiotonic, antihyperlipidemic, antiatherogenic, antioxidant; Karanja[13] having hypolipidemic, hypoglycemic action. It was observed that methanolic bark extract of Kadara (Acacia suma Kurz.) [14] is potential to prevent the secondary complications of diabetes mellitus like atherosclerosis. Daruharidra[15] has hypoglycemic, hypolipidemic, and anti-inflammatory activities; Dhava (Anogeissus latifolia Wall.) [16] shows hypolipidemic and hepatoprotective activity, whereas Khadira[17] is well-known of having anti-dyslipidemic and anti-diabetic property.
Anti-inflammatory drugs are potential enough for endothelial protection by reducing endothelial injury. Anti-oxidant drugs reduce chances of atherosclerotic complications like CVA (cerebrovascular accident), whereas hypoglycemic drugs improve carbohydrate metabolism and glycogenesis by reducing excess lipogenesis . Hepatoprotective drugs enhance the enzyme useful for HDL production. Over all AG is cardioprotective and hepatoprotective. Ultimately, it is useful to regulate lipid metabolism
Probable mode of action of GH
Due to Dustikara Nidana, it increases Sama Sleshma, Agnimandhya and Amarasa. Rasagata Ama manifests symptoms such as Apachita Medo Dhatu Vridhhi, Bharavridhhi, Angagaurava, Sroto-avarodha. And Sama Sleshma causes symptoms such as Angagaurava, Sroto-avarodha, Ati Kshudha, Ati Pipasa, and Asthi-Sandhishoola. It may lead to Ama Bahula Samprapti Janya Vyadhi such as Medoroga, Madhyama Margavaranajanya Vyadhi, Trimarmiya Vyadhi. Gomutra (of GH) possesses Katu Rasa and Ushna Virya, whereas Haritaki has property of Doshanuloman, Dipana-pachana, Sroto Vibandhanahara, Pramehahara, Hridaya-urah Pralepahara, and Budhhi Indriya Bala Prada. GH increases Jatharagni by Amapachana reducing Sama Sleshma and Apachita Medo Dhatu. GH probably works at the level of Jatharagni.
Triglyceride and other cholesterol are usually absorbed in gastro-intestinal tract (GIT). When Jatharagni Vikriti occurs, it manifests in Ama, disturbs lipid metabolism, increases triglyceride and other cholesterol. GH improves physiological digestion process at the level of the intestine and liver. It also regulates lipid metabolism. Gomutra[18] (bio-enhancer) can enhance the efficacy and effect of other drugs. Haritaki[19] has anti-hyperlipidemic, anti-oxidant, cytoprotective, anti-diabetic, cardioprotective as well as hepatoprotective activity. Over all, GH is cardioprotective and hepatoprotective, and it promotes physiological digestive process.
| Conclusion | | |
On comparison, both drugs Asanadi Ghanavati and Gomutra Haritaki showed better result on dyslipidemia. Asanadi Ghanavati is more useful in pre-diabetic and diabetic, dyslipidemic patients while Gomutra Haritaki has an additional advantage of improving physiological digestive process. Asanadi Ghanavati probably works at the level of Medodhatwagni. Gomutra Haritaki probably works at the level of Jatharagni. Asanadi Ghanavati and Gomutra Haritaki should be used in Kleda Bahul Samprapti Janya Vyadhi and Ama Bahul Samprapti Janya Vyadhi respectively. The ingredients of Gomutra Haritaki are cost-effective and easily available throughout the country. Finally, Gomutra Haritaki is a potent drug in the management of dyslipidemia both as a prophylactic and curative agent.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]
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