A clinical trial to study the effects of two drugs, Shigru kwatha and Livogrit in patients with Non Alcoholic Fatty Liver Disease

Phase 2/3

Not yet recruiting

• Conditions: Inflammatory liver disease, unspecified. Ayurveda Condition: YAKRUDDALYUDARAH,

• Registration Number: CTRI/2023/10/058382
• Lead Sponsor: Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan

Brief Summary

This study is a open label double arm comparative study , comparing the efficacy of Shigru Kwatha 100 ml twice daily before meal and Livogrit tablet each 500mg 2 tablet twice daily before meal in 40 patients with Yakritvikara that will be conducted in OPD no. 13/14 in Patanjali Ayurvedic hospital, Haridwar. Assessment will be done on the basis of subjective and objective parameter.

Route of administration- Oral Route



Follow up- follow up will be done to observe effects of treatment or any adverse effect on the patient.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-05-10
• Study Start: 2023-10-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patient between the age group of 18 to 65 years will be selected.
• Patient irrespective of gender, religion, occupation and chronicity will be selected for the study.
• Both fresh and treated cases would be taken for the study.
• Patient with Grade 1 and Grade 2 fatty liver only will be selected for the study.
• Individual with controlled Diabetes Mellitus having Grade 1 and Grade 2 fatty liver will be selected for the study.

Exclusion Criteria

• 1.Pregnant or lactating women will be excluded.
• Patient who have had Hepatitis B,C or other hepatic viral infection , autoimmune hepatitis and drug induced hepatitis or alcoholic hepatitis will be excluded.
• Patient with severe complication of the cardiovascular, renal or hematopoietic systems and mental disease will be excluded.
• Patient will be excluded having decompensated liver disease.
• Patient with prolonged or a history of ascites , developed Hepatocellular carcinoma Hepatic Encephalopathy , Variceal bleeding will be excluded.
• Patient with a history of using IFN or antiviral agents or Corticosteroids or Immunosuppresive drugs will also be excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Subjective criteria	0th day 30th day 60th day
1. Anorexia	0th day 30th day 60th day
2. Fatigue	0th day 30th day 60th day
3. Abdominal pain	0th day 30th day 60th day
4. Malaise	0th day 30th day 60th day
5. Indigestion(avipaka)	0th day 30th day 60th day
6. Polydipsia (pipasa)	0th day 30th day 60th day
7. Constipation	0th day 30th day 60th day
8. Vomiting (chhardi)	0th day 30th day 60th day
9. Fever (mridu jwara)	0th day 30th day 60th day
10. Flatulence (aanaha)	0th day 30th day 60th day
11. Tastelessness	0th day 30th day 60th day

Secondary Outcome Measures

Name	Time	Method
Objective Criteria	1. Ultrasonography whole abdomen

Trial Locations

Locations (1)

Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan; 🇮🇳 Hardwar, UTTARANCHAL, India

Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan

🇮🇳Hardwar, UTTARANCHAL, India

DrRajan Dalel

Principal investigator

8532994444

rajandalel0404@gmail.com