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A clinical trial to compare the effects of coded Unani research drug UNIM-118 with Silymarin in patients with Hepatitis A/B/C/E

Phase 2
Conditions
Health Condition 1: B179- Acute viral hepatitis, unspecifiedHealth Condition 2: null- Hepatitis A/B/C/E
Registration Number
CTRI/2013/12/004256
Lead Sponsor
Central Council for Research in Unani Medicine CCRUM New Delhi
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
632
Inclusion Criteria

1.Patients of both sexes.

2. Patients in the age group of 18-65 years

3. Patients with positive serological markers for at least for one of these â?? Hepatitis A/B/C/E

4.Patients having total Bilirubin in the range of 2 -15 mg %

Or

5.• Patients with SGPT in the range of 105- 1000 IU/L

Or

6.• Any of the following symptoms and signs suggestive of viral hepatitis:

ô??? Yaraqan Asfar (Yellow coloration of eye & skin)

ô??? Iâ??ya (Fatigue)

ô??? Wajaâ??al-Kabid (Hepatalgia)

ô??? Zuâ??f al-Ishtihaâ?? (Anorexia)

ô??? GhathayÄ?n (Nausea)

ô??? Qai (Vomiting)

ô??? Humma (Fever)

ô??? Bawl Nasâ??e (Dark coloured urine)

ô??? Siql-e-Tahtush Sharasif Aiman (Heaviness in the right hypochondrium)

ô??? Lahib-e-Tahtush Sharasif Aiman (Burning sensation in the right Hypochondrium)

ô??? Aversion to tea / smoking

ô??? Naqs al-Wazn (Loss of weight)

Exclusion Criteria

1.Patients with serum Bilirubin level 15 mg %

2.Patients with complications of acute viral hepatitis

3.Patients with signs of advanced liver disease, including muscle-wasting, ascites, peripheral oedema, dilated abdominal veins, and caput medusa

4.H/o T.B./ D.M./ HIV/ CHF/ Malignancy/ Epilepsy

5.USG suggestive of cirrhosis/ amoebic liver abscess/gall stones/ obstructive jaundice

6.Alcoholics

7.Pregnant and lactating women.

8.Obese patients with BMI 30

9.Patient on any other treatment including use of alternative medicine for hepatitis.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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