A randomized comparative clinical trial to study the effect of Classical and Nitya Virechana followed by Internal administration of Vidangadi Kshara yoga in Non-Alcoholic fatty liver disease.

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 hadAnnavaha, 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 Karmabetween Classical Virechana and Nitya Virechana:

In SamyakaVirikta Lakshana as Antiki, Vegiki, Laingiki Shuddhi, Classical Virechanawas 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 Virechanaand 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 Shamanain 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 Shamanain group B.

Improvementobserved in SGOT was 8.97% after Classical Virechana and 15.01% after Shamanain group A whereas 5.15% decrease after Nitya Virechana and 11.11% afterShamana in group B. Decrease found in SGPT was 27.40% after Classical Virechanaand 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 Shamanain 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 Virechanaand 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)

 Â§  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 Virechakaare used for maintaining the liver and digestive system. It possesses manydifferent qualities, such as hepatoprotective, lipid peroxidation-reducing, andhypolipidemic qualities.

 Â§  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.