Evaluation of efficacy of Sufoof-e-Akseer-e-Jigar in Alcoholic Hepatitis.
Phase 2
- Conditions
- Health Condition 1: null- alcoholic hepatitis
- Registration Number
- CTRI/2014/11/005196
- Lead Sponsor
- Govt Nizamia Tibbi College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
•Patients clinically diagnosed with Alcoholic Hepatitis.
•Patients of both genders with age range between 20-60 years.
•Patient should be off from any other therapy for the same ailment 1 week prior to his/her enrollment.
•Patients who are willing to give written consent.
Exclusion Criteria
•Patients below 20 years and above 60 years.
•Pregnant and lactating mothers.
•Diabetic patients.
•Patient suffering from other systemic diseases.
•Patients who does not give written consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relief from clinical symptoms and physical signs (Subjective Parameters viz., Anorexia, Nausea,Vomiting,Anxiety,Restlessness, Pain in Abdomen, Low grade Fever, Yellow coloured Urine) along with improvement of biochemical parameters (Objective Parameters viz., Serum γ-glutamyl transferase, Serum Bilirubin, SGOP, SGPT, Alkaline Phosphotase, Hepatomegaly). <br/ ><br> <br/ ><br>An Arbitrary Grading Scale will be adopted for the assessment of subjective parameters. <br/ ><br>Timepoint: Day 1 <br/ ><br>Day 15 <br/ ><br>Day 30 <br/ ><br>Day 45 <br/ ><br>Day 60
- Secondary Outcome Measures
Name Time Method Short-Term safety as assessed by change in the safety biochemical parameters (like CBP, ESR, FBS, PPBS, LFT, RFT), and overall compliance to the drug treatment.Timepoint: Day 1 <br/ ><br>Day 60