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To study the effect of bhunimbadi churna vati in alcoholic hepatitis

Phase 3
Conditions
Health Condition 1: K701- Alcoholic hepatitis
Registration Number
CTRI/2023/08/056282
Lead Sponsor
Dr Amatullah Ataullah Dalvi
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1. Able to provide written consent.

2. Male or female patients between 22- 55 yrs of age.

3. AST Value 50u/l to 400u/l

4. Total bilirubin in the range of 2 mg/dl to 15mg/dl.

5. AST:ALT > 1.5

Exclusion Criteria

1.Other liver pathology like viral hepatitis, drug induced hepatitis, non-alcoholic hepatitis,

immunocompromised patients.

2.Patient with alcoholic withdrawal symptoms such as hallucination, abusive, agitated &

aggressive behavior.

3. K/C/O - liver cirrhosis, liver cancer & ascites.

4.K/C/O - renal disorder, cardiac disorder, hypertension and other chronic disorder, endocrinological

disorder.

5.K/C/O - Hemochromatosis, Wilson disease and other autoimmune disorder.

6.Pregnant & lactating women.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
SUBJECTIVE CRITERIA- <br/ ><br>1.Twacha-peetavarna (Yellowish discoloration of skin) <br/ ><br>2.Nakha-peetavarna (Yellowish discoloration of nails) <br/ ><br>3.Peeta-netrata(Yellowish discoloration of eyes) <br/ ><br>4.Peeta mutra varna <br/ ><br>(Yellowish discoloration of urine) <br/ ><br>5.Peet-shakrit(Yellowish discoloration of stool) <br/ ><br>6.Mukha- peetata <br/ ><br>(Yellowish discoloration of face) <br/ ><br>7.Jwar (Fever) <br/ ><br>8.Shudhamandya <br/ ><br>(Loss of appetite) <br/ ><br>9.Daurbalya <br/ ><br>(Weakness) <br/ ><br>10.Aruchi <br/ ><br>(Loss of taste) <br/ ><br>11.Hrullas (Nausea) <br/ ><br>OBJECTIVE CRITERIA- <br/ ><br>CBC,LFTTimepoint: Baseline and After 4 weeks
Secondary Outcome Measures
NameTimeMethod
A.Changes in Subjective parameters like <br/ ><br>1.Twacha peetavarna <br/ ><br>2.Nakha peetavarna <br/ ><br>3.Peeta netrata <br/ ><br>4.Peeta mutra varna <br/ ><br>5.Peeta shakrit <br/ ><br>6.mukha peetata <br/ ><br>7.Jwar <br/ ><br>8.Shudhamandya <br/ ><br>9.Daurbalya <br/ ><br>10.Aruchi <br/ ><br>11.Hrullas. <br/ ><br>B.Changes in objective parameters like CBC & LFT which includes <br/ ><br>1.serum bilirubin <br/ ><br>2.AST-ALT ratio.Timepoint: Baseline & after 4 weeks
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