| CTRI Number |
CTRI/2008/091/000090 [Registered on: 19/06/2008] |
| Last Modified On: |
|
| Post Graduate Thesis |
|
| Type of Trial |
|
|
Type of Study
|
|
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Clinical Trial to study the efficacy & safety of Colebrookea Oppositifolia (Aceteoside) in acute hepatitis patients. |
|
Scientific Title of Study
|
A double blind, placebo controlled comparative, randomized study to evaluate efficacy & Safety of Colebrookea Oppositifolia (Aceteoside) in acute hepatitis A/B Patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol I.D. – RLH – AC |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR. HARMEET SINGH REHAN |
| Designation |
|
| Affiliation |
|
| Address |
PROFESSOR & HEAD DEPT OF PHARMACOLOGY
LADY HARDINGE MEDICAL COLLEGE & SMT S.K. HOSPITAL
New Delhi
DELHI
110001
India |
| Phone |
09811694040 |
| Fax |
011 – 23408151 |
| Email |
harmeetrehan@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR. HARMEET SINGH REHAN |
| Designation |
|
| Affiliation |
PROFESSOR & HEAD DEPT OF PHARMACOLOGY, LADY HARDINGE MEDICAL COLLEGE & SMT S.K. HOSPITAL, NEW DELHI – 110001 |
| Address |
PROFESSOR & HEAD DEPT OF PHARMACOLOGY
LADY HARDINGE MEDICAL COLLEGE & SMT S.K. HOSPITAL
New Delhi
DELHI
110001
India |
| Phone |
09811694040 |
| Fax |
011 – 23408151 |
| Email |
harmeetrehan@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR. K. A. Suri |
| Designation |
|
| Affiliation |
|
| Address |
Scientist, NPC Division, Indian Institute of Integrative Medicine
Canal Road
Jammu
JAMMU & KASHMIR
180001
India |
| Phone |
09419131836 |
| Fax |
0191-2569333 |
| Email |
kasuri.iiim@gmail.com |
|
|
Source of Monetary or Material Support
|
| Council of Scientific & Industrial Research |
|
|
Primary Sponsor
|
| Name |
Council of Scientific & Industrial Research |
| Address |
|
| Type of Sponsor |
|
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Indian Institute of Integrative Medicine |
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR. HARMEET SINGH REHAN |
LADY HARDINGE MEDICAL COLLEGE & ALLIED HOSPITALS |
PROFESSOR & HEAD DEPT OF PHARMACOLOGY,LADY HARDINGE MEDICAL COLLEGE & SMT S.K. HOSPITAL-110001
New Delhi
DELHI |
09811694040
011 – 23408151
harmeetrehan@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, LADY HARDINGE MEDICAL COLLEGE & ALLIED HOSPITALS, NEW DELHI - 110001 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Acute Hepatitis A/B, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Tablet 25 Mg Placebo |
Tablet 25 mg TDS for 6 weeks |
| Intervention |
Tablet 25 Mg. 25 Mg with water soluble fraction of Colebrookea oppositifolia extract |
Tablet 25 mg TDS for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
1. Individuals between 18-60 years of age of either sex suffering from acute hepatitis A/B. Diagnosis will be made on the basis of clinical history or immunological markers.
2. Patients ready to abide by trial procedures and to give informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Patients over 60 years or less than 16 years of age.
2. Pregnant or lactating mothers / complicated with Non A & B Hepatitis or Drug / alcoholic hepatitis / chronic active hepatitis.
3. Suspicion of auto – immune disease concomitant presence of disease of Cardiovascular System, renal or haemopoietic System or mental disease.
4. Patients using drugs which are likely to affect liver function tests e.g. NSAID’s, Anticonvulsants, anti-diabeitic, statins , hormones, erythromycin etc.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome measures will be improvement in liver function tests, immunological test and liver ultrasound imaging as compared to base line using appropriate statistical test. |
6 weeks onwards |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/07/2008 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
|
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is double blind placebo controlled, randomized clinical trial to evaluate the efficacy & safety of Colebrookea Oppostitifolia (Aceteoside) in acute hepatitis patients A/B. Acetoside is aqueous Extract obtained from the dried & powdered aerial parts of the Colebrookea Plant. Patients meeting inclusion criteria will be randomized & divided in two groups, one group will receive Acteoside 25 mg T.D. S and other group placebo 25 mg TDS for a period of Six weeks, the primary out come measure will be statistical improvement in liver function tests like S.Bil, S.Alt, S.Ast, S. Albumin S. Alkaline phosphate & prothrombin time these will be assessed at base line, 1 wk, 2 wks, 4 wks, & 6 wks.
Immunological Tests - 1 gm anti HBC anti body, S.HBeAG, and 1 gm Anti HAV anti body, HBsAg, Anti HBs antibody , S.HBeAg, ANTI Hbe Ab, 1 gm ANTI HAV antibody and liver ultrasound imaging. Adverse drug reaction (ADR) monitoring will be done throughout the study as per the pharmacovigilance programme.
|