Treatment of Non-Alcoholic fatty liver disease by Virechana(Purgation therapy) and Vidangadi Kshara yoga.
- Conditions
- Fatty (change of) liver, not elsewhere classified. Ayurveda Condition: YAKRUDDALYUDARAH,
- Registration Number
- CTRI/2022/02/040355
- Lead Sponsor
- Institute of Teaching and Research in Ayurveda
- Brief Summary
In study of 20 patients, maximum number ofpatients i.e., 40% were from age group of 51 to 60 years and 90% were Male inpresent study. Maximum numbers of patients i.e., 95% were Hindu, 90 % weremarried and 60% were from middle class society. Among the total, 45% were doingservice/ Job, 80 % were residential from urban area and 80% were having habitatin *Anupa Desha.*
Maximum numbers of the patients i.e., 65%were vegetarian, 40% were having habit of irregular eating and out of 20patients 85% had salty taste dominant diet followed by 70% sweet and 65% sourdominant diet habit. 95% had habit to consume *Guru* (heavy)and 75%had *Snigdha* (unctuous) *Guna* dominant diet.
Majority of the patients i.e., 55% had *VishamaAgni* (improper digestive power)*,* 60% had *Madhyama Kostha,* 65%of them have *Sama Mala Pravartana,* and only 10% patients had *PrabhutaMutrata* (polyuria). Maximum patients i.e. 45% were not used to do exercise,75% had sedentary lifestyle, 25% of them had disturbed sleep and 30% of totalhad been suffering from stress or anxiety. Out of 2 females, 100% were havingmenopause.
35% each of the patients were having *VataKapha* and *Pitta Kapha Prakriti and,* 70% were having *RajasaPrakriti,* 85% with *Madhyama Sara,* 85% with *Madhyama Samhanana,* 65%with *Sthula Pramana,* 85% were having *Madhyama Rasa Satmyata,* 75%were with *Madhyama Satva,* 75% were having *Madhyama Abhyavarana Shakti*(moderate intake capacity) and 95% were with *Madhyama Jarana Shakti* (lowdigestive capacity)*.* 75% of patients were having *Madhyama VyayamaShakti.* 55% of total were having chronicity between 1 to 3 years.
90% of total patients are having habit ofconsuming *Abhisyandi* and *Vidahi Ahara* 80% of total patients werehabituated to take unctuous, *Viruddha* diet, 85% were having habit of daysleep and 75% were inactive in work. 55 % patients found to have relax/distressful life, which are the probable causes found in majority of thepatients. 75% had *Pitta Kapha Dosha Vikriti* and all of them had*Annavaha, Rasavaha* and *Raktavaha Srotodusti.* 85% of the patientshad *Medovaha Srotodusti.*
Allof the patients had presented with four of the cardinal symptoms of NAFLDi.e.Fatigue, Nausea, Belching, Fever, Itching, Vomiting, Jaundice, Abdominal Pain, Burningsensation in abdomen, Abdominal heaviness, Abdominal distension, Flatulence etc.100% of the patients had association of Flatulenceand Abdominalheavinesswhile 95% had Abdominal distension, 85% had been suffering from Abdominal Pain andfatigue, at time of enrollment. 80% had Burning sensation in abdomen*,* 70%had belching*,* 35% had Itchingfollowed by 30% had been sufferingfrom Nauseaas symptoms.
During the assessment of *Virechana* (therapeuticpurgation)*,* half of the patients i.e. 4 had taken *Goghrita* (cow’sghee) with maximum dose between 170 to 190 ml during *Snehapana* (internaloleation)*,* 80% of them were having *Vatanulomana* (downwardmovement of flatulence)*,* 40% had *Diptagni* (increased digestivepower)*,* 90% *Adhastata Snehadarshana* (oily appearance in feces)and 100% had *Snigdha Angata* (oily appearance of skin and organs) as *SamyakaSnigdha Lakshana*(symptoms of proper oleation)*,* 100% of them had *MadhyamaShudhhi* (moderate therapeuatic purgation)*,* 70% had *KaphantaVirechana* followed by 30% had *Vatanta Virechana* and all of them had *LaingikiSudhhi* with *Kramena Vit-pita-kapha-vata Pravartana* (expulsion inorder) and *Laghava* (lightness) followed by 100% of patients had *Vatanulomana*(downward movement of flatulence) and 20% *Agni Vridhhi Lakshana* (increaseddigestive power)*.*
In assessment of *Nitya Virechana Karma,*50% (5) of patients given *Nitya Virechana Dravya* between 15-20grams/day, and 50% (5) had taken 21-25 grams/ day. 50 % of the patients hadevacuated in 2-4 hours after administration of *Virechana yoga* while 30%had evacuated between 4- 6 hours. 100% of them had *Avaraa Shudhhi* (inadequatetherapeuatic purgation)*,* 40% had *Malanta Virechana* followed by 90%each had *Vatanta and Kaphanta Virechana* and 90% of them had *LaingikiSudhhi* with *Kramena Vit-pita-kapha-vata Pravartana* (expulsion inorder) and 90% *Laghava* (lightness) followed by 100% of patients had *Vatanulomana*(downward movement of flatulence) and 60% *Agni Vridhhi Lakshana* (increaseddigestive power)*.*
**Results observed in study**
**In cardinal symptoms**;
In group A, after *VirechanaKarma,* highly significant (p<0.001) result was found in nausea (100%),belching (89%), heaviness of abdomen (70%), flatulence (70%); very significant(p<0.01) results were observed in fatigue (57.14%), burning in abdomen(62.5%); significant (p<0.05) result was observed in abdominal distension(33.33%); insignificant result was found in vomiting and itching.
In group B, after *NityaVirechana Karma,* highly significant (p<0.001) result was found inbelching (71.42%), burning in abdomen (87.5%), heaviness of abdomen (90%),flatulence (60%); very significant (p<0.01) results were observed inabdominal distension (40%); insignificant result was found in fatigue, nausea,fever, abdominal pain and itching.
In group A, afteroverall therapy*,* highly significant (p<0.001) result was found infatigue (100%), nausea (100%), belching (100%), abdominal pain (100%),heaviness of abdomen (100%), burning in abdomen (100%), abdominal distension(100%), flatulence (100%); very significant (p<0.01) results were observedin itching (100%).
In group B, afteroverall therapy*,* highly significant (p<0.001) result was found infatigue (80%), belching (100%), abdominal pain (100%), heaviness of abdomen(100%), abdominal distension (100%), flatulence (100%); very significant(p<0.01) results were observed in burning in abdomen (75%); andinsignificant result found in nausea, fever, and itching.
Most of theobservations found were statistically significant within group and comparisonof the change found in two of the groups was statistically insignificant insymptomatic criteria except abdominal heaviness and flatulence. Percentage wiseand clinically better relief was observed in group A than Group B.
**In effective of *Karma*between Classical *Virechana* and *Nitya Virechana:***
In *SamyakaVirikta Lakshana* as *Antiki, Vegiki, Laingiki Shuddhi,* Classical *Virechana*was more Significant than *Nitya Virechana.*
**In Objective criteria:**
Differenceof pH (fecal material) between classical and *Nitya Virechana* showedmajor changes in Group A. Improvement observed in Cholesterol was 13.51% afterClassical *Virechana* and 16.31% after *Shamana* in group A whereas5.41% decrease after *Nitya Virechana* and 1.43% after *Shaman* ingroup B. Decrease found in Triglyceride was 25.54% after Classical *Virechana*and 51.29% after *Shamana* in group A whereas 13.31% decrease after *NityaVirechana* and increased by 1.31% after *Shamana* in group B. Decreasefound in S. LDL was 17.81% after Classical *Virechana* and 14.14% after *Shamana*in group A whereas 4.07% decrease after *Nitya Virechana* and decreased by4.62% after *Shamana* in group B. Decrease found in S. VLDL was 26.43%after Classical *Virechana* and 28.44% after *Shamana* in group Awhereas 3.56% increase after *Nitya Virechana* and increased by 15.04%after *Shamana* in group B. Increase found in S. HDL was 3.52% afterClassical *Virechana* and 9.37% after *Shamana* in group A whereas2.29% increase after *Nitya Virechana* and increased by 3.91% after *Shamana*in group B.
Improvementobserved in SGOT was 8.97% after Classical *Virechana* and 15.01% after *Shamana*in group A whereas 5.15% decrease after *Nitya Virechana* and 11.11% after*Shamana* in group B. Decrease found in SGPT was 27.40% after Classical *Virechana*and 33.82% after *Shamana* in group A whereas 12.56% decrease after *NityaVirechana* and decreased by 16.39% after *Shamana* in group B. Decreasefound in ALP was 4.40% after Classical *Virechana* and 3.77% after *Shamana*in group A whereas 0.55% decrease after *Nitya Virechana* and increased by2.65% after *Shamana* in group B. Decrease found in Total Bil. was 48.53%after Classical *Virechana* and 29.46% after *Shamana* in group Awhereas 5.83% increase after *Nitya Virechana* and decreased by 4.47%after *Shaman* in group B.
Decreasein value observed in Total Bile Acids was 0.80% after Classical *Virechana*and in group A whereas 0.36% decrease after *Nitya Virechana* in group B.Decrease in BMI observed was 4.90% after Classical *Virechana* and ingroup A whereas 2.74% decrease after *Nitya Virechana* in group B.
Percentagewise and clinically better relief was observed in group A than Group B inprimary outcome of Lipid Profile, Hepatic profile, BMI, Total bile acids, USGchanges. (Table no. 6.109 to 6.112)
§ **Probable** **mode of action of *VirechanaKarma and Trivruttadi Virechana yoga***
§ *Trivruttadi Virechana Yoga* holds significance for *VirechanaKarma*, that is used to treat NAFLD. It is having *Tikta*, *Katu,Kashaya Rasa, Laghu, Ruksha, Tikshna Guna, Ushna Virya. Katu Vipaka.* Drugswith the qualities of *Kapha- Pittashamaka, Deepana,* and *Virechaka*are used for maintaining the liver and digestive system. It possesses manydifferent qualities, such as hepatoprotective, lipid peroxidation-reducing, andhypolipidemic qualities.
§ **Probable mode of action of *Vidangadi Kshara yoga*:**
*Vidangadi Kshara yoga* having *Katu Rasa, Laghu,Tikshna Guna, Ushna Virya. Katu Vipaka. Katu Rasa,* *Laghu, Teekshna Guna,Ushna Virya* does *Srotoshodhana* by removing *Ama and Kapha* from thechannels and improves *Agni* breaking further pathogenesis of disease. It possesses *Deepana,* *Kapha dosha hara, Shoolaghna*, *Medohara* antioxidant, anti-inflammatory,antifibrotic, hypolipidemic properties.
§ **Adverse drug reaction**
No adverse effect was observed in patients during the clinical trials. Thisshows that both formulations *Trivruttadi Virechana Yoga* and *VidangadiKshara yoga* are quite safe for internal administration and can also begiven as treatment to cases of NAFLD.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
- Both freshly detected and previously diagnosed cases of NAFLD.
- USG findings are suggestive of NAFLD Grade I, II &III.
- aged below 25 years and above 60 years, Pregnant women.Uncontrolled diabetes or hypertension, Complications of Metabolic syndrome-like Cerebrovascular accident, Myocardial Infarction, Chronic Kidney disease.
- Ayogya for Virechana karma in group A.
- Patients consume hepatotoxic medicines, alcohol, or other narcotic substances.
- Cirrhosis, Ascites, variceal hemorrhage, coagulopathy, hepatorenal syndrome.
- History of viral hepatitis, autoimmune liver diseases (Primary biliary cirrhosis, primary sclerosing cholangitis, autoimmune hepatitis), metabolic disorders (Wilson’s disease, hemochromatosis), HIV, TB other infectious diseases, malignancies, Major psychiatric problems.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Samyaka Virikta Lakshana is to be assessed. Patients will be assessed after 15 days (After completion of Virechana Karma). Stool color, Stool odor, pH of stool after Virechana Karma. Patients will be assessed after 15 days (After completion of Virechana Karma). BMI - Before and after treatment. Patients will be assessed after 15 days (After completion of Virechana Karma). Changes in signs and symptoms of NAFLD. Patients will be assessed after 15 days (After completion of Virechana Karma).
- Secondary Outcome Measures
Name Time Method Changes in signs and symptoms of NAFLD. USG of Abdomen-changes of fatty liver and/or cholestasis.
Trial Locations
- Locations (1)
PG Hospital, ITRA, Jamnagar
🇮🇳Jamnagar, GUJARAT, India
PG Hospital, ITRA, Jamnagar🇮🇳Jamnagar, GUJARAT, IndiaShreya MarsoniyaPrincipal investigator9974567545shreya.marsoniya13@gmail.com