Indiscriminate and repeated use of alcohol produces a gradual, physical, and moral deterioration of the individual, culminating in crimes or perversions. Despite the untoward effects of alcohol, alcoholism is a major problem in India, with an estimated prevalence rate of 16%–50%.[1,2] Daily alcohol use of more than 60–80 g/day for males and 20–40 g/day for females for 10–12 years is attributed to a 25-fold greater risk of developing alcoholic liver disease (ALD). This concomitant is referred to as Madya Janya Yakrit vikara in Ayurveda, and it manifests as Pandu (anemia), Kamala (jaundice), and Udara (ascites), with yakritodara (hepatomegaly) being the cardinal symptom. There is a need for medicine that can act on every unit of health while also ensuring safety and efficacy. Therefore, a polyherbal formulation, Patoladi Gana Kashaya, having hepatoprotective, nootropic, antihyperlipidemic, and choleretic properties, was opted to investigate its effectiveness in ALD (Madya Janya Yakrit Vikara).
Materials and Methods
This study was an open-label, single-arm (uncontrolled) before and after study, with pre- and posttest design in 30 individuals. The ethical clearance was obtained from the Institutional Ethics Committee (IEC No: SDM/IEC/33/2014–2015). The study was registered under the Clinical Trial Registry India (REF/2016/06/011559). The study individuals were recruited from the Outpatient Department of SDM College of Ayurveda Hospital, Hassan, based on diagnostic criteria such as clinical findings, an elevated liver function test with or without symptoms of jaundice, and a predefined symptom scale.
Consenting (in written form) individuals diagnosed with per aforesaid criteria, aged between 30 and 60 years, irrespective of gender, socioeconomic, and religious background, were included.
Individuals with advanced stages of ALD, other systemic illnesses, or suffering from other chronic psychiatric illnesses, organic brain diseases, and under hormonal or psychiatric treatment were not included in the study.
Individuals were allowed to withdraw from the trial in case of any adverse reaction from the trial drug or worsening of clinical condition.
All individuals were treated with polyherbal formulation Patoladi Gana Kashaya two pala (90 ml) in three divided doses of 30 ml after food with equal warm water for 30 days. The trial drug was purchased from an authentic pharmacy. Ingredients are tabulated in Table 1.
Subjective parameters such as Mandagni (reduced appetite), Jwara (fever), Chardi (vomiting), Peetanetrata, Peetashakrith, Peetamutrata (yellowish discoloration of conjunctiva, feces, and urine, respectively), Udarashula (pain abdomen), Baddhashakrith (constipation), and Daaha (burning sensation) were ranked either present or absent and were assessed pre- and posttest. Objective parameters such as liver function test and lipid profile were employed in the study.
The overall effect of the therapy was graded in terms of complete remission (100%), marked improvement (75%–99%), moderate improvement (50%–74%), mild improvement (25%–49%), and unchanged (<24% reduction in chief complaints).
SPSS (Statistical Package for the Social Sciences) version 23 (IBM Corp., Armonk, N.Y., USA) was used to tabulate and analyze the collected data. Descriptive statistics were used to analyze demographic data and other relevant information. Ordinal data were analyzed using nonparametric tests such as Cochran‘s Q, McNemar test, and objective parameters by t-test. The changes (one tailed) with P < 0.05 were considered statistically significant.
Thirty-six individuals diagnosed with Madyajanya Yakrit Vikara and who fulfilled the eligibility criteria were enrolled in the study. Six individuals dropped out due to personal commitments. Thirty individuals completed the study. The incidences of age, sex, religion, socioeconomic status, occupation, etc., noted in the patients of this study were as follows. Of the maximum individuals, 97.2% were male aged between 40 and 50 years (41.70%). Seventy percent of individuals were from the middle class, 72.2% were married, and 55.6% were business owners. Among the total number of individuals (36 patients), 80.6% of them had their first drink in life between 20 and 30 years of age. For 1–5 years, 72.2% of people consumed alcohol daily, with rum (47.2%) and brandy (38.9%) being the most common. The majority of patients (58.2%) drank between 90 and 180 ml of alcohol. The individuals had a conflicted family atmosphere. About 58.33% of individuals had a conflicted family atmosphere.
Most prevalent symptoms were Mandagni (97.2%), Peetamootrata (80.6%), Peetashakrith (66.7%), Udarashoola (58.3%), Baddhashakrith (50%), and Peeta netrata (41.7%). Eighty percent had a mild level of severity.
Effect of intervention
The polyherbal formulation Patoladi gana kashaya has shown a 46.28% improvement in total bilirubin level, a 47.7% and 55.42% improvement in direct and indirect bilirubin levels, respectively, with statistical significance. With statistical significance [Table 2], there was a 58.58% and 68.9% improvement in serum glutamic-oxaloacetic transaminase and serum glutamic-pyruvic transaminase levels, respectively. Overall, total cholesterol levels improved by 5.5%, high-density lipoprotein levels improved by 5.4%, and low-density lipoprotein levels improved by 8.7% with statistical significance [Table 3]. In subjective parameters, statistical significance was obtained in Mandagni, Jwara, Chardi, Udarashoola, Baddhashakrith, and Peetanetrashakruthmootrata (P < 0.05) [Tables 4 and 5]. Overall Patoladi Gana Kashaya has shown marked improvement in 40% of patients and moderate improvement in 60% of patients.
The study showed a higher incidence of the subject population in the fourth decade of life, and the first drink to be in the second decade of life. The finding is similar to the study by Benegal et al. (2005) who also reported the average duration of abuse to be 10–12 years. Mohan et al. the majority of drinkers were moderate drinkers, which is also seen in this study. The role of alcohol in domestic violence is seen in this study and also cited in an Indian study which found that 33% of spouse-abusing husbands were using alcohol and more than half of the spousal abuse took place during the period of intoxication. Regardless of the severity of the disease process, the most common physical examination finding in patients with either steatosis or alcoholic hepatitis is hepatomegaly which was found in our study. The classic also suggests the cardinal symptom of Yakrit Vikara (liver disease) to be Yakritodara (hepatomegaly). The vast majority of patients with ALD will have elevated liver function along with an altered lipid profile, which was seen in this study as well. Excessive alcohol (Madya), Vidahi, and Abhishyandi Ahara vitiates Agni, Pitta, and Yakrit (liver) resulting in Rakta Pradoshaja Vyadhi and/or Yakrit Vikara. From this perspective, we can deduce that excessive alcohol consumption deteriorates liver functions, resulting in liver disease, and hence clinical features of ALD counterpart Madya Janya Yakrit Vikara.
In general, liver disorders are contemplated as disorders of Pitta origin. It is due to the invariable relationship between rakta-pitta-agni (the vital components of metabolism). The line of management opted is virechana-madhyama shodhana (moderate elimination of deranged pitta)). In this regard, the trial drug Patoladi Gana Kashaya aims at breaking the chain of disease manifestation. It is tikta rasa (bitter taste) predominant, ushna veerya (hot potency), katu vipaka (hot potency), rooksha (dry), and laghu (light) in nature. It mostly targets pitta and kapha dosha, and contains pittasaraka (thaw pitta out of the body), deepana (kindle digestion), pachana (digestive), anulomana (corrects functioning of vata dosha), and bhedana (choleretics)[12,13] properties. The drug which has cholesteric properties stimulates the secretion of bile and causes virechana. The laghu guna aids easy absorption, assimilation, and anulomana. Individually, Patola has been shown in animal studies to have adaptogenic, anti-inflammatory, anti-proliferative, and laxative effects. Katukarohini picrosides I and II have been shown in molecular studies to have hepatoprotective, anti-toxin, and antioxidant properties.[18,19] The ethanol and aqueous stem bark extract of Raktachandana afforded significant protection against CCl4-induced hepatocellular injury.Neema et al. (2011) investigated the hepatotoxicity of murva. The antihepatotoxic activity of Guduchi has been demonstrated in CCl4-induced liver damage, normalizing liver function as assessed by morphological and biochemical parameters.Patha has also been shown in experimental models to have anti-inflammatory, diuretic, hepatoprotective, antioxidant, and immune modulator activity. Patola and Chandana have been shown to have antihyperlipidemic activity in studies. This formulation also possesses medahara (antihyperlipidemic), kaphahara (reducing kapha dosha) actions, thus yielding better results in improving the lipid profile. In short, choleretic, hepatoprotective, hepatocurative, and antihyperlipidemic properties of the trial drug might have yielded a better outcome when compared to the baseline value. Overall, Patoladi Gana Kashaya has shown marked improvement in 40% of patients and moderate improvement in 60% of patients.
Considering the complication of ALD to be cirrhosis, ascites, and portal hypertension, the study limits itself in generalizing its results. The small sample size and restricted resources for conducting the trial are also drawbacks. As the majority of the participants were alcoholic dependants, additional trials involving psychotherapy might be conducted to see if it has a potentiating effect on pharmaceutical intervention, independent therapeutic outcomes, or both.
The polyherbal formulation (Patoladi Gana Kashaya-30 ml t.i.d. after food with 30 ml of warm water) is an effective option clinically in the management of Madya Janya Yakrit Vikara (alcohol liver disease). The polyherbal formulation is also helpful in the restoration of normal liver function and lipid profile. We assume that the ingredients initially acted on agni as deepana and pachaka and later as pitta rechaka. No adverse effects were reported by the individuals during the study. It is important to reproduce this study using larger samples and standard assessment tools.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
We acknowledge our Principal, Dr. (Prof) Prasanna Narasimha Rao for invariable support and guidance throughout the study period. We also acknowledge all the subjects for their active participation.
1. Eashwar VM, Umadevi R, Gopalakrishnan S. Alcohol
consumption in India-An epidemiological review. J Family Med Prim Care 2020; 9: 49–55.
2. Murthy P, Manjunatha N, Subodh BN, Chand PK, Benegal V. Substance use and addiction research in India. Indian J Psychiatry 2010; 52: S189–99.
3. Singal AK, Anand BS. Recent trends in the epidemiology of alcoholic liver disease
. Clin Liver Dis (Hoboken) 2013; 2: 53–6.
4. Sharma BS, Vidyotini Hindi Comm. Bhavaprakasha, Bhavamishra Part 2. Uttarasthana, Ch. 33., Ver. 10 7th ed Varanasi Chaukhamba Sanskrit Samsthana 2000: 348–50.
5. Ashtanga Hridaya, Sutrasthana Shodhanadiganasangrahadiadhyaya, 15/15 Available from: http://ayurvidya.net/shastra/hridayam/?mod=read
Last accessed on 2022 May 15.
6. Benegal V, Nayak M, Murthy P, Chandra P, Gururaj G Obot IS, Room R Alcohol
Gender and Drinking Problems –Perspective from Low and Middle Income Countries; 5 Geneva, Switzerland World Health Organization 2005: 89–123.
7. Mohan D, Chopra A, Ray R, Sethi H. Alcohol
consumption in India:A cross sectional study Room R, Demers A, Bourgault C Surveys of Drinking Patterns and Problems in Seven Developing Countries Geneva World Health Organization 2001: 103–14.
8. Benegal V, Velayudhan A, Jain S. Social costs of alcoholism:A Karnataka perspective. NIMHANS J 2000; 18: 67.
9. Frazier TH, Stocker AM, Kershner NA, Marsano LS, McClain CJ. Treatment of alcoholic liver disease
. Therap Adv Gastroenterol 2011; 4: 63–81.
10. Torruellas C, French SW, Medici V. Diagnosis of alcoholic liver disease
. World J Gastroenterol 2014; 20: 11684–99.
11. Charaka Samhita, Vimanasthana, Srotovimana Adyaya, 5/8 Available from: https://niimh.nic.in/ebooks/ecaraka/?mod=read
Last accessed on 2022 May 15.
12. Rao RK, Kumar SN, Jones S, Elizabeth AA, Prabhu K. Phytochemical and GC MS analysis of an ayurvedic formulation, patolakaturohinyadi kwatham. Int J Pharm Sci Rev Res 2015; 34: 6–12.
13. Pawar S, Kadam R, Jawale S. An open randomized study of patola katurohinyadi kashayam in alcoholic liver disease
. IJAPR 2015; 3: 15–21.
14. Kumar N, Singh S, Manvi, Gupta R. Trichosanthes dioica
Roxb.:An overview. Pharmacogn Rev 2012; 6: 61–7.
15. Bhattacharya S, Haldar PK. The triterpenoid fraction from Trichosanthes dioica
root suppresses experimentally induced inflammatory ascites in rats. Pharm Biol 2013; 51: 1477–9.
16. Bhattacharya S, Haldar PK. The triterpenoid fraction from Trichosanthes dioica
root exhibits antiproliferative activity against Ehrlich ascites carcinoma in albino mice:Involvement of possible antioxidant role. J Exp Ther Oncol 2012; 9: 281–90.
17. Bhattacharya S, Haldar PK. Trichosanthes dioica
root possesses stimulant laxative activity in mice. Nat Prod Res 2012; 26: 952–7.
18. Tiwari SS, Pandey MM, Srivastava S, Rawat AK. TLC densitometric quantification of picrosides (picroside-I and picroside-II) in Picrorhiza kurroa
and its substitute Picrorhiza scrophulariiflora
and their antioxidant studies. Biomed Chromatogr 2012; 26: 61–8.
19. Kant K, Walia M, Agnihotri VK, Pathania V, Singh B. Evaluation of antioxidant activity of Picrorhiza kurroa
(Leaves) extracts. Indian J Pharm Sci 2013; 75: 324–9.
20. Kshirsagar AD, Mohite R, Aggrawal AS, Suralkar UR. Hepatoprotective medicinal plants of Ayurveda-A review. Asian J Pharm Clin Res 2011; 4: 1–8.
21. Nema AK, Agarwal A, Kashaw V. Hepatoprotective activity of Leptadenia reticulata
stems against carbon tetrachloride-induced hepatotoxicity in rats. Indian J Pharmacol 2011; 43: 254–7.
22. Nagarkatti DS, Rege NN, Desai NK, Dahanukar SA. Modulation of Kupffer cell activity by Tinospora cordifolia
in liver damage. Postgrad Med 1994; 40: 65–7.
23. Bafna A, Mishra S. Antioxidant and immunomodulatory activity of the alkaloidal fraction of Cissampelos pareira
linn. Sci Pharm 2010; 78: 21–31.
24. Rai PK, Jaiswal D, Singh RK, Gupta RK, Watal G. Glycemic properties of Trichosanthes dioica
leaves. Pharm Biol 2009; 46: 894–9.
25. Kulkarni CR, Joglekar MM, Patil SB, Arvindekar AU. Antihyperglycemic and antihyperlipidemic effect of Santalum album
in streptozotocin induced diabetic rats. Pharm Biol 2012; 50: 360–5.