| CTRI Number |
CTRI/2016/10/007365 [Registered on: 14/10/2016] Trial Registered Prospectively |
| Last Modified On: |
17/12/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of poly herbal formulation in chronic inactive carriers of hepatitis B virus |
|
Scientific Title of Study
|
Antiviral effect of 3 herbs in chronic inactive carriers of hepatitis B virus- A randomized placebo controlled clinical trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| OI-002-2016 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Alben Sigamani |
| Designation |
Group Head Clinical Research |
| Affiliation |
Narayana Hrudayalaya Hospital |
| Address |
1st Floor, B Block, Narayana Health City, Bommasandra Industrial Area, Bangalore 560099, Karnataka State, INDIA
Bangalore
KARNATAKA
560099
India |
| Phone |
8884431444 |
| Fax |
|
| Email |
alben.sigamani.dr@nhhospitals.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjaya Chauhan |
| Designation |
Clinical Research Associate |
| Affiliation |
Organic India |
| Address |
Organic India Private Limited – R&D
8th Floor, A Block, Mazumdar Shaw Cancer Centre
Narayana Health City, Bommasandra Industrial Area
Bangalore 560099, Karnataka State, INDIA
Bangalore
KARNATAKA
560099
India |
| Phone |
9611252350 |
| Fax |
|
| Email |
drsanjayachauhan49@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sindhu N |
| Designation |
Ayurvedic Clinical investigator |
| Affiliation |
Organic India |
| Address |
Organic India Private Limited – R&D
8th Floor, A Block, Mazumdar Shaw Cancer Centre
Narayana Health City, Bommasandra Industrial Area
Bangalore 560099, Karnataka State, INDIA
Bangalore
KARNATAKA
560099
India |
| Phone |
99026423747 |
| Fax |
|
| Email |
reddysindhu993@gmail.com |
|
|
Source of Monetary or Material Support
|
| Organic India Private Limited – R&D 8th Floor, A Block, Mazumdar Shaw Cancer Centre Narayana Health City, Bommasandra Industrial Area Bangalore 560099, Karnataka State, INDIA |
|
|
Primary Sponsor
|
| Name |
Organic India |
| Address |
Organic India Private Limited – R&D 8th Floor, A Block, Mazumdar Shaw Cancer Centre Narayana Health City, Bommasandra Industrial Area Bangalore 560099, Karnataka State, INDIA |
| Type of Sponsor |
Other [Herbal Supplement Manufacturer] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Alben Siagamani |
Mazumdar Shaw Medical Centre, Narayana Health |
Department of Clinical Research, 1st Floor, B Block, Narayana Health City, Bommasandra Industrial Area, Bangalore 560099, Karnataka State, INDIA
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
8884431444
alben.sigamani.dr@nhhospitals.org |
| Dr Vineet Kumar Shukla |
K.R.M Hospital and Research Centre |
3/92-93, Vijayant Khand, Gomti Nagar, Lucknow-226010,Uttar Pradesh, India
Lucknow
UTTAR PRADESH |
9554540710
krmhrclko@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| KRM Hospital Ethics Committee |
Approved |
| Narayana Health Medical Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Inactive chronic hepatitis B or immune tolerant phase of chronic hepatitis B, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo inert capsule |
Inert similar looking capsule. All the participant will be asked to take 2 inert similar looking capsules twice daily at a fixed time for 12 months. |
| Intervention |
Polyherbal Capsule |
Each capsule contains 3 herbs: Phyllanthus niruri, Boerhaavia diffusa, Picrorhiza kurora. All the participants will be instructed to take 3 capsules twice daily at a fixed time in the day for 12 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged above 18 years of age, with inactive chronic hepatitis B or immune tolerant phase, with or without dyslipidaemia and having all of the following
1.HBsAg +ve for >6 months and anti-HBs negative
2.Alanine amino transferase ≤ 2 upper limit of normal(ULN)
3.HBeAg positive or negative irrespective of viral DNA load
4.Not currently on antiviral therapy for Chronic hepatitis B
|
|
| ExclusionCriteria |
| Details |
Any one of the following
1.Patients with decompensated liver disease of any etiology(characterized by elevated bilirubin, raised INR, or a history of ascites, variceal hemorrhage,hepatic encephalopathy, Spontaneous bacterial peritonitis, hepatorenal syndrome or Hepatocellular carcinoma)
2.Family history of hepatocellular carcinoma
3.Patients with HIV and HCV co-morbidity
4.Pregnant, attempting to conceive, or lactating women
5.Patients with diabetes mellitus
6.Recent history of acute coronary syndrome (<6months) or chronic coronary artery disease with poor left ventricular function (by physician / cardiology opinion)
7.Patients with renal failure ( Creatinine clearance less than 60 ml/min)
8.Active substance or alcohol abuse and concurrent use of corticosteroids or immunosuppressive agents.
9.Presence of extra hepatic manifestations
10.Previously treated with pegylated interferon within the last 2 years
11.Positive fibroscan or ultrasound elastography showing evidence of fibrosis (F3 and above)
12.Current or former employees of organic India
13.Participating in another clinical trial with an active intervention or drug or device with last dose taken within 60 days.
14.Refusing consent or physician uncomfortable with patient compliance to treatments or follow up.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| The primary outcome is a change from baseline in mean HBV DNA by at least 2log10 units at end of treatment – 12 months for those with HBV DNA ≥ 1000 IU/ml. |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of patients with incidence of seroconversion from Hepatitis B surface antigen to anti-hepatitis B antibody. |
12 months |
| Number of patients with resurgence of HBeAg positivity. |
12 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
N/A |
|
Date of First Enrollment (India)
|
25/10/2016 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Nearly 37 million Indians are carriers of Hepatitis B virus. Current therapies have not been effective in clearing the virus completely. Herbal medications are commonly used in treating acute and chronic hepatitis B infections. The aim of this trial is to study the effect of a poly herbal capsule containing 3 herbs: Bhumyamalaki (Phyllanthus niruri), Punarnava (Boerhaavia diffusa) and Katuki (Picrorhiza kurroa) in lowering viral load and increasing incidence of seroconversions in Hepatitis B surface antigen. Treatment will be given for 12 months and outcomes will be compared at end of treatment period. We hypothesize that 30 – 40% more patients, will clear the surface antigen in the active arm compared to placebo.
|