Efficacy of Sharapunkhadi yoga and life style modification in the management of Non Alcoholic Fatty Liver Disease
- Conditions
- Fatty (change of) liver, not elsewhere classified, USG findings suggestive of NAFLD Grade I, II & III,
- Registration Number
- CTRI/2016/02/006623
- Lead Sponsor
- IPGT AND RA
- Brief Summary
**Conceptual Study**
Non Alcoholic Fatty Liver Disease (NAFLD) is simply fat deposition in the liver that is not caused by chronic ingestion of alcohol. NAFLD encompasses a spectrum of liver disorders characterized by macro vesicular hepatic fat accumulation alone (steatosis), or accompanied by signs of hepatocyte injury, mixed inflammatory cell infiltrate and variable hepatic fibrosis (Non-Alcoholic Steato Hepatitis - NASH), leading to cirrhosis. Approximately, 20% to 30% of adults in the general population in western countries have NAFLD and its prevalence increases to 70% to 90% among persons who are obese or have diabetes. Epidemiological studies suggest prevalence of NAFLD in around 9% to 32% of general population in India with a higher prevalence in those with obesity and diabetes/prediabetes. NASH can progress to cirrhosis and end-stage liver disease and is projected to be the leading cause of liver transplantation by 2020. NAFLD is overall associated with an increased cardio metabolic risk
NAFLD is a disease occurring as a result of improper energy utilization and disturbed metabolism, owing to hampered function of Agni. The consumption of high calorie food like oily , fried food, fast food, milk products, artificial sweetners, sweetened beverages, fermented food along with sedentary lifestyle and reduced physical work results in storage of energy, which ultimately impede function of *Agni*, which leads to the formation of *Apakva Anna rasa, Kapha Dushti* and *Medo vridhi* esp. at *Yakrit.* Considering the etiological factors of NAFLD, it can be included under the broad heading of *Santarpanajanya Vyadhi*, which simulates *Agni Vikriti* ie. *Ajirna* ; and *Medoroga* ie. Sthoulya in etio- pathogenesis and clinical presentation. The conditions which mentions the term ‘*Yakrit’* in Ayurvedic classics are *Yakriddalyudara, Yakritvidradhi and Yakritgulma* which can be considered as the end stage of Fatty Liver.
.**Plan of Study**
· Study type : Randomized, placebo-controlled, open label, clinical trial
· No. of groups : Two
Group A - *Sharapunkhadi Yoga* Capsules and lifestyle modification
Group B - Placebo (roasted sooji powder) Capsules and lifestyle modification
Method of randomization - Computer generated randomization method
· Sample size : Total 93 patients
Ø Group A - No. of patients enrolled – 46
No. of drop out - 3
No. of completed patients - 43
Ø Group B - No. of patients enrolled – 47
No. of drop out - 7
No. of completed patients - 40
**Treatment Protocol**
*Sharapunkhadi Yoga* is a formulated combination comprises of equal quantities of extracts of *Sharapunkha, Bhoomiamalaki and Katuki.* Placebo capsule was prepared with roasted sooji powder. *Mriduvirechana* with *Haritaki Churna* was performed in both the groups prior to the trial. In both groups, two capsules (each 500mg) were administered thrice daily with luke warm water, before meals. Duration of the trial was 8 weeks. Patients in both groups were advised for lifestyle modification. Detailed *Pathyaapathya* chart was prepared and given to patients. Follow up was done for four weeks after the completion of treatment to assess the long-standing effect of the drug. During follow-up period, no any specific medical treatment was given to the patients.
**Assessment and Analysis**
Assessment was made mainly based on the improvement observed in the subjective parameters - *Agnivaishamya*, fatigue, nausea, belching, vomiting, itching, burning abdomen, burning chest, abdominal pain, heaviness and distention, flatulence, diarrhea and constipation and objective parameter - grade of fatty liver; before treatment and after treatment. Statistical analysis was done with the help of paired ‘t’ test to assess the effect of intervention within the group with unpaired ‘t’ test to assess the comparative effect of intervention between the groups.
**Demographic observations**
v In the study populace, maximum number of patients belonged to age group of 41-50 years (37.63%) followed by 27.96% patients of 51-60 years age group. 53.76% patients were males. Majority of them belonged to Hindu religion (87%) and urban area(73.12%). 37.63% patients were having college education and 40% patients were of mid to high school level education. 39.78% patients were housewives and 34.41% patients doing deskwork. Maximum number of patients (58.06%) were from middle socio-economic class, followed by poor patients(39.79%). Maximum reported chronicity is 1-5 years in 49.46% of patients, followed by less than 1 year period chronicity in 29.03% of patients.
v While analyzing the dietary habits of patients, maximum number of patients were afflicted to *Katu Rasa Ahara* (46.24%) followed by *Madhura* *Rasa* *Ahara* (35.48%); *Guru Guna Pradhana* (64.52) and *Snigdha Guna Pradhana* (63.44%) *Ahara* followed by *Ushna Guna Pradhana Ahara* (39.78%); observing irregular dietary habit (67.74%) and vegetarian food (76.34%). Most of patients were reported having the habit of *Diwaswapa* (94.62%) and Av*yayama* (50.54%).
v 30.11% patients were suffering from *Tikshnagni*, followed by *Mandagni* (25.8%) and *Vishamagni* (13.98%) .46.24%% patients were observed having *Krura Koshtha* and 19.35% patients having *Mridu Koshtha*. 52.69% patients were observed with *Achintana* and 44.09% patients with *Atichintana*. Maximum number of patients had *Kaphapittaja* *Prakriti* (45.15%) followed by *Vatapitta* *Prakriti* (40.86%)
v The symptoms reported include abdominal distention in maximum number of patients(91.4%), followed by abdominal heaviness (88.17%), fatigue (77.42%), abdominal pain (64.52%), belching (61.29%), flatulence (52.69%), burning abdomen (51.61%), constipation (46.24%), nausea (40.86%), increased appetite and itching (31.18% each) and decreased appetite (29.03%). 19.35% patients were reported to have suffering from vomiting and diarrhea. 6.45% patients were having fever and 5.38% were having burning chest.
v Maximum number of patients (73.12%) were reported having BMI more than 25kg/m2; overweight patients (39.79%), grade 1 obese (22.58%), grade 2 obese (6.45%) and grade 3 obese (4.3%).
v Majority of the patients were diagnosed having grade 1 fatty liver (93.55%), followed by 5.37% patients of grade 2 and 3.5% patients of grade 3 fatty liver.
v Maximum number of patients were reported having the symptoms of *Vata Vridhi* (98.92%) and *Vata Prakopa* (31.18%), followed by *Pitta Vridhi* (65.59%) and *Pitta Prakopa (*2.15%); and *Kapha Vridhi* (36.56%) and *Kapha Prakopa*(13.98%).
v All patients included in the study were observed having *Annavaha Srotodushti. Purishavaha Srotodushti* in 91.4% of patients, *Rasavaha Srotodushti in* 68.82% patients, *Medovaha Srotodushti* in 66.67% of patients; and *Swedavaha Srotodushti* reported in 56.99% of patients.
**Effect of intervention**
v On completion of eight weeks of treatment, 72.1% decrease was reported for *Agnivaishamya* in group A and 23.36% decrease in group B. Fatigue was decreased by 77.48% in group A and 38.03% in group B. Nausea was decreased by 74.11% in group A and 29% in group B. Belching was decreased by 76.19% in group A and 29.76% in group B. 74.94% decrease was reported for itching in group A and 24.07% decrease in group B. Relief of 73.64% for abdominal pain in group A and 21.49% in group B. All these differences were statistically significant. On comparing the effect of therapy between two groups, it was found that the difference of percentage decrease in above mentioned symptoms of both groups was statistically significant and group A provided better relief than group B.
v Burning abdomen was relieved by 56.34% in group A and 22.73% in group B. 80.82% relief was reported for abdominal heaviness in group A and 28.37% in group B. Relief of 78.89% was observed for abdominal distention in group A and 27.21% in group B. 71.45% decrease for flatulence in group A and 26.87% decrease in group B. Diarrhea was relieved by 68.75% in group A and 26.22% in group B. Decrease of 67.69% was reported for constipation in group A and 18.01% decrease in group B. All the above differences were statistically significant. On comparing the effect of therapy between two groups, it was found that the difference of percentage decrease in above mentioned symptoms of both groups was statistically significant and group A provided better results than group B
v In case of vomiting, 73.33% decrease was reported in group A after treatment and the difference is statistically significant. 21.74% relief was obtained in group B for vomiting, but the difference was non-significant. In burning chest, both the groups failed to provide significant results.
v There was statistically significant improvement by about 39.25% in Group A and 31.82% in group B, in the grades of fatty liver.
v All the biochemical parameters including blood sugar level, lipid profile, liver function test, renal function test are within the normal range before starting the trial and after completion of the trial.
v Group B has shown statistically significant increase in FBS, PPBS and serum cholesterol after the trial period by about 14.46%, 11.47% and 9.8% respectively. Although the increase in the mean values were reported within the normal limits, this shows that lifestyle modification may not be sufficient for preventing the building up of insulin resistance and alterations for lipid metabolism.
v Significant decrease for about 11% was reported for S. creatinine in group A. This shows that *Sharapunkhadi Yoga* is safe and can be administered without any adverse reaction in the kidney.
v Significant increase of haemoglobin by 2.69% and RBC by 2.59% was reported in group B. All the other haematological parameters were not significantly affected in both the groups after the trial period
**Overall effect of therapy**
In group A, complete remission was not observed in any of the patients. Excellent improvement was observed in 15(34.88%) patients. Marked improvement was observed in 8(18.6%) patients. Moderate improvement was observed in 20(46.51%) patients. Mild and nil response were not observed in any of the patients. In group B, complete remission, excellent response and nil response were not observed in any of the patients. Marked improvement was observed in 2(5%) patients. Moderate improvement was observed in 10(25%) patients. Mild improvement was observed in 28(70%) patients. This shows that the combination of *Sharapunkhadi Yoga* and lifestyle modification can yield more significant result in the management of NAFLD, than lifestyle modification alone.
**Probable mode of action of *Sharapunkhadi Yoga***
All the ingredients in *Sharapunkhadi Yoga* are having *Tikta Rasa*. *Tikta Rasa* possess *Deepana, Pachana*, *Lekhana*, *Medashoshana* properties. The formulation is having *Tikta* *Kashaya Rasa*, *Ruksha* *Laghu* *Guna*, *Sheeta* *Veerya,* *Katu* *Vipaka and Kapha Pitta Shamaka* properties. *Sharapunkha* and *Katuki* have *Deepana* property. *Deepana*, *Pachana* properties of *Sharapunkhadi Yoga* corrects the digestive process and prevent formation of *Ama. Bhoomiamalaki* and *Katuki* due to its *Lekhana* property can open the obstructed channel and remove *Srotorodha* and thus prevent *Vatakopa*. Excessive amount of *Meda* accumulated can be removed only by means of *Shoshana*, which is done by *Tikta* *Rasa* and *Ruksha* *Guna.* *Sharapunkha* and *Katuki* have *Yakriduttejaka* and *Pittavirechaka* property. *Bhoomiamalaki* and *Katuki* are having *Medohara* property, thus decrease the level of circulating lipids and prevent hepatic accumulation of lipids.
*Tephrosea purpurea* contain flavonoids which produce hepatocellular membrane stability, prevention of cellular leakage and increasing of hepatic regeneration. Poly phenolic compounds and flavonoids in leaves having anti-oxidant, free radical scavenging and hepatoprotective activity. Hepatoprotective and anti-oxidant activity of Phyllanthus niruri have been attributed to two novel lignin phytochemicals named *phyllanthin* and *hypophyllanthin.* Methanolic extract of *Phyllanthus* specieswas found to inhibit lipid peroxidation & scavenge hydroxyl and superoxide radicals. Hepatoprotective effect of *Katuki* is due to the presence of picroside I, picroside II and kutkoside which are present in rich quantities in the roots and rhizomes of *P. kurroa.* Apocynin is a constituent of root extracts of *Katuki* which possess anti inflammatory properties. Therapeutic action on NAFLDof *Sharapunkhadi Yoga* may be attributed to its pharmacological properties and presence of phytoconstituents.
**Lifestyle Modification**
All the international guidelines report that lifestyle changes that include diet and exercise are the only therapeutic approach recommended for NAFLD. Regular *Yogic* practices can play a big role in maintaining the body weight, reducing waist circumference, decreasing levels of circulatory lipids and are more sufficient than vigorous exercise in the management fatty liver. *Gomukhasana, Ardhamatsyendrasana, Pavanamuktasana, Dhanurasana, Bhujangasana, Kapalabhati* etc*.* have been adviced to the patients according to BMI and flexibility. Walking in the fresh air was also advised. Patients were advised to practice *Kalabhojana* for proper functioning of *Agni* and *Upavasa* at times to burn out excess *Meda.* Intake of vegetables and fruits rich in flavonoids and polyphenols was encouraged. *Rooksha Dravas* like *Takra* and *Ushnajala* were recommended as they are having *Medoshoshana* property.
As all lifestyle disorders , NAFLD can also be considered as a psychosomatic disease, *Eershya, Bhaya, Kroda, Shoka, Achintana, Atichintana* are instructed to be avoided and *Dhyana, Patana, Madhyama Marga Sheelana* are tobe followed. Instruction was given to avoid *Avyayama, Avyavaya, Svapnaviparyaya, Divasvapna, Vegadharana, Atapa anala sevana, Atimatrabhojana, Heenabhojana, Akalabhojana* etc*.* as all these habits will provoke *Agni* and *Vata* and increase the amount of *Sthayi* and *Asthayi Medo dhatu.* Continuous and strict followal of lifestyle intervention can prevent the incidence of NAFLD in normal subjects, reverse the pathology, regain normalcy and can prevent progression to further stages such as NASH in NAFLD patients
**Adverse drug reaction**
No undesirable effect was observed in patients during the clinical trials. This shows that the *Sharapunkhadi Yoga* is a formulation which is quite safe for internal administration. No exaggeration of symptoms was reported in placebo group also, as lifestyle modification can prevent the sudden flaring up of the disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 80
Patients of either sex of age group above 25 yrs and below 60yrs USG findings suggestive of Non Alcoholic Fatty Liver Disease grade I II III Both freshly detected and previously diagnosed cases of NAFLD.
Patient aged below 25 years and above 60 years pregnant ladies Patients with uncontrolled diabetes or hypertension Patients with complications of Metabolic syndrome like Cerebrovascular accident Myocardial Infarction Chronic Kidney disease Patients consuming hepatotoxic medicines alcohol or other narcotic substances Patients suffering from Cirrhosis Ascites variceal haemorrhage coagulopathy hepato renal syndrome Patients having history of viral hepatitis auto immune liver diseases like Primary biliary cirrhosis primary sclerosing cholangitis autoimmune hepatitis metabolic disorders like Wilsons disease haemochromatosis Patients suffering from HIV TB other infectious diseases malignancies major psychiatric problems or any other serious illnesses.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method It is expected that the trial drug will normalize Liver Function tests and reverse fatty changes of liver 8 weeks
- Secondary Outcome Measures
Name Time Method By providing better effect on Non Alcoholic Fatty Liver Disease drug may reduce the risk of Non Alcoholic Steato Hepatitis Fibrosis Cirrhosis Ascites and further complications of end stage liver disease and thus improve quality of life. 8 weeks treatment and 4 weeks follow up
Trial Locations
- Locations (1)
IPGT & RA
🇮🇳Jamnagar, GUJARAT, India
IPGT & RA🇮🇳Jamnagar, GUJARAT, IndiaRemya EPrincipal investigator9447378133drremyaenair@gmail.com