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

A Multi centric, Single Blind, Randomized, parallel group study to compare efficacy and safety of coded unani formulation UNIM-118 with Silymarin in patients with Waram al-Kabid/ Hepatitis A/B/C/E

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/12/004256

Enrollment

632

Registered

2013-12-30

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B179- Acute viral hepatitis, unspecified Health Condition 2: null- Hepatitis A/B/C/E

Interventions

Intervention1: UNIM-118: Dose: 2 tablets (500 mg each) three times a day The total duration of treatment will be 8 weeks for Hepatitis A and E and 12 weeks for Hepatitis B and C Control Intervention1:

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Improvement in symptoms and signs of hepatitis. â?¢ Improvement in biochemical liver parameters. â?¢ Haematological and biochemical assessments for safety Timepoint: 8 weeks for Hepatitis A and E 12 weeks for Hepatitis B and C	—

Secondary

Measure	Time frame
Clearance of HBsAg /HCV RNATimepoint: 8 weeks for Hepatitis A and E 12 weeks for Hepatitis B and C	—

Countries

India

Contacts

Public ContactDr Abdul Hannan

Central Council for Research in Unani Medicine (CCRUM)

ccrum605@gmail.com011-28522965

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026