In study of 20 patients, maximum number of patients i.e., 40% were from age group of 51 to 60 years and 90% were Male in present study. Maximum numbers of patients i.e., 95% were Hindu, 90 % were married and 60% were from middle class society. Among the total, 45% were doing service/ Job, 80 % were residential from urban area and 80% were having habitat in Anupa Desha.

Maximum numbers of the patients i.e., 65% were vegetarian, 40% were having habit of irregular eating and out of 20 patients 85% had salty taste dominant diet followed by 70% sweet and 65% sour dominant 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 Vishama Agni (improper digestive power), 60% had Madhyama Kostha, 65% of them have Sama Mala Pravartana, and only 10% patients had Prabhuta Mutrata (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 total had been suffering from stress or anxiety. Out of 2 females, 100% were having menopause.

35% each of the patients were having Vata Kapha and Pitta Kapha Prakriti and, 70% were having Rajasa Prakriti, 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 (low digestive capacity). 75% of patients were having Madhyama Vyayama Shakti. 55% of total were having chronicity between 1 to 3 years.

90% of total patients are having habit of consuming Abhisyandi and Vidahi Ahara 80% of total patients were habituated to take unctuous, Viruddha diet, 85% were having habit of day sleep and 75% were inactive in work. 55 % patients found to have relax/ distressful life, which are the probable causes found in majority of the patients. 75% had Pitta Kapha Dosha Vikriti and all of them had Annavaha, Rasavaha and Raktavaha Srotodusti. 85% of the patients had Medovaha Srotodusti. 

All of the patients had presented with four of the cardinal symptoms of NAFLD i.e. Fatigue, Nausea, Belching, Fever, Itching, Vomiting, Jaundice, Abdominal Pain, Burning sensation in abdomen, Abdominal heaviness, Abdominal distension, Flatulence etc. 100% of the patients had association of Flatulence and Abdominal heaviness while 95% had Abdominal distension,  85% had been suffering from Abdominal Pain and fatigue, at time of enrollment. 80% had Burning sensation in abdomen, 70% had belching, 35% had Itching followed by 30% had been suffering from Nausea as symptoms.   

During the assessment of Virechana (therapeutic purgation), half of the patients i.e. 4 had taken Goghrita (cow’s ghee) with maximum dose between 170 to 190 ml during Snehapana (internal oleation), 80% of them were having Vatanulomana (downward movement of flatulence), 40% had Diptagni (increased digestive power), 90% Adhastata Snehadarshana (oily appearance in feces) and 100% had Snigdha Angata (oily appearance of skin and organs) as Samyaka Snigdha Lakshana(symptoms of proper oleation), 100% of them had Madhyama Shudhhi (moderate therapeuatic purgation), 70% had Kaphanta Virechana followed by 30% had Vatanta Virechana and all of them had Laingiki Sudhhi with Kramena Vit-pita-kapha-vata Pravartana (expulsion in order) and Laghava (lightness) followed by 100% of patients had Vatanulomana (downward movement of flatulence) and 20% Agni Vridhhi Lakshana (increased digestive power). 

In assessment of Nitya Virechana Karma, 50% (5) of patients given Nitya Virechana Dravya between 15-20 grams/day, and 50% (5) had taken 21-25 grams/ day. 50 % of the patients had evacuated in 2-4 hours after administration of Virechana yoga while 30% had evacuated between 4- 6 hours. 100% of them had Avaraa Shudhhi (inadequate therapeuatic purgation), 40% had Malanta Virechana followed by 90% each had Vatanta and Kaphanta Virechana and 90% of them had Laingiki Sudhhi with Kramena Vit-pita-kapha-vata Pravartana (expulsion in order) and 90% Laghava (lightness) followed by 100% of patients had Vatanulomana (downward movement of flatulence) and 60% Agni Vridhhi Lakshana (increased digestive power).   

Results observed in study

In cardinal symptoms; 

In group A, after Virechana Karma, 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 Nitya Virechana Karma, highly significant (p<0.001) result was found in belching (71.42%), burning in abdomen (87.5%), heaviness of abdomen (90%), flatulence (60%); very significant (p<0.01) results were observed in abdominal distension (40%); insignificant result was found in fatigue, nausea, fever, abdominal pain and itching.

In group A, after overall therapy, highly significant (p<0.001) result was found in fatigue (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 observed in itching (100%).

In group B, after overall therapy, highly significant (p<0.001) result was found in fatigue (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%); and insignificant result found in nausea, fever, and itching.

Most of the observations found were statistically significant within group and comparison of the change found in two of the groups was statistically insignificant in symptomatic criteria except abdominal heaviness and flatulence. Percentage wise and clinically better relief was observed in group A than Group B.

In effective of Karma between Classical Virechana and Nitya Virechana:

In Samyaka Virikta Lakshana as Antiki, Vegiki, Laingiki Shuddhi, Classical Virechana was more Significant than Nitya Virechana.

In Objective criteria:

Difference of pH (fecal material) between classical and Nitya Virechana showed major changes in Group A. Improvement observed in Cholesterol was 13.51% after Classical Virechana and 16.31% after Shamana in group A whereas 5.41% decrease after Nitya Virechana and 1.43% after Shaman in group B. Decrease found in Triglyceride was 25.54% after Classical Virechana and 51.29% after Shamana in group A whereas 13.31% decrease after Nitya Virechana and increased by 1.31% after Shamana in group B. Decrease found 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 by 4.62% after Shamana in group B. Decrease found in S. VLDL was 26.43% after Classical Virechana and 28.44% after Shamana in group A whereas 3.56% increase after Nitya Virechana and increased by 15.04% after Shamana in group B. Increase found in S. HDL was 3.52% after Classical Virechana and 9.37% after Shamana in group A whereas 2.29% increase after Nitya Virechana and increased by 3.91% after Shamana in group B.

Improvement observed 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 Nitya Virechana and decreased by 16.39% after Shamana in group B. Decrease found 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 by 2.65% after Shamana in group B. Decrease found in Total Bil. was 48.53% after Classical Virechana and 29.46% after Shamana in group A whereas 5.83% increase after Nitya Virechana and decreased by 4.47% after Shaman in group B.

Decrease in 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 in group A whereas 2.74% decrease after Nitya Virechana in group B.

Percentage wise and clinically better relief was observed in group A than Group B in primary outcome of Lipid Profile, Hepatic profile, BMI, Total bile acids, USG changes. (Table no. 6.109 to 6.112)

§  Probable mode of action of Virechana Karma and Trivruttadi Virechana yoga

§  Trivruttadi Virechana Yoga holds significance for Virechana Karma, that is used to treat NAFLD. It is having Tikta, Katu, Kashaya Rasa, Laghu, Ruksha, Tikshna Guna, Ushna Virya. Katu Vipaka. Drugs with the qualities of Kapha- Pittashamaka, Deepana, and Virechaka are used for maintaining the liver and digestive system. It possesses many different qualities, such as hepatoprotective, lipid peroxidation-reducing, and hypolipidemic 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 the channels 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. This shows that both formulations Trivruttadi Virechana Yoga and Vidangadi Kshara yoga are quite safe for internal administration and can also be given as treatment to cases of NAFLD.