Chronic Hepatitis BNCT02899130
Effect of Polyherbal Formulation in Chronic Inactive Carriers of Hepatitis B Virus
A study testing Polyherbal in people with Chronic Hepatitis B, run by Composite Interceptive Med Science at 1 site in India.
Trial summary
This trial will study the effect of a polyherbal capsule in lowering the viral load of patients with chronic Hepatitis B infection and record the incidence of from Hepatitis B surface antigen elimination in 12 months Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- Polyherbal
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteIndia
- Study dates
- Oct 2016to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged above 18 years of age, with inactive chronic hepatitis B (HB) or immune tolerant phase, with or without dyslipidaemia and having all of the following
- HBsAg +ve for >6 months and anti-HBs negative
- Alanine amino transferase ≤ 2 upper limit of normal
- HBeAg positive or negative irrespective of viral DNA load
- Not currently on antiviral therapy for Chronic hepatitis B
Who cannot join
- Any one of the following
- Patients with decompensated liver disease of any etiology(characterized by elevated bilirubin, raised International normalized ratio, or a history of ascites, variceal hemorrhage,hepatic encephalopathy, Spontaneous bacterial peritonitis, hepatorenal syndrome or Hepatocellular carcinoma)
- Family history of hepatocellular carcinoma
- Patients with HIV and Hepatitis C virus co-morbidity
- Pregnant, attempting to conceive, or lactating women
- Patients with diabetes mellitus
Show all 15Show fewer
- Recent history of acute coronary syndrome (<6months) or chronic coronary artery disease with poor left ventricular function (by physician / cardiology opinion)
- Patients with renal failure ( Creatinine clearance less than 60 ml/min)
- Active substance or alcohol abuse and concurrent use of corticosteroids or immunosuppressive agents.
- Presence of extra hepatic manifestations
- Previously treated with pegylated interferon within the last 2 years
- Positive fibroscan or ultrasound elastography showing evidence of fibrosis (F3 and above)
- Current or former employees of organic India
- Participating in another clinical trial with an active intervention or drug or device with last dose taken within 60 days.
- Refusing consent or physician uncomfortable with patient compliance to treatments or follow up.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Mazumdar Shaw Mutispeciality Hospital
Bangalore, Karnataka, 560099
Alben Sigamani, MD
About this study
Official title: Antiviral Effect of 3 Herbs in Chronic Inactive Carriers of Hepatitis B Virus. - A Randomized Placebo Controlled Clinical Trial
This trial will study the effect of a polyherbal capsule in lowering the viral load of patients with chronic Hepatitis B infection and record the incidence of from Hepatitis B surface antigen elimination in 12 months
Read the detailed description
A placebo controlled randomised trial. 3 herbs that have proven effect on eliminating the virus and normalizing liver function will be given. Equally matched placebo (blinded) will be given randomly to patients. All parameters of hepatitis B infection will be compared between the randomized groups
- Conditions
- Chronic Hepatitis B
- Being tested
- Polyherbal, Placebo
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolyherbalDrug
Also called Liver Kidney Care
Each capsule contains 3 herbs. Phyllanthus niruri, Boerhaavia diffusa, picrorhiza kurroa
PlaceboDrug
Inactive compound that is similar looking as the intervention
| Study group | Role | What they receive |
|---|---|---|
| Polyherbal | Experimental | Combination of 3 whole herbs in a capsule Receives: Drug: Polyherbal |
| Matching placebo | Placebo comparator | Similar looking inert capsules Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with change in mean Hepatitis B Virus (HBV) DNA by at least 2log10 units from baseline at end of treatment for those with HBV DNA ≥ 1000 IU/ml.
Measured: 12 months
Secondary outcomes (2)
Number of patients with change in hepatitis B surface antigen titers from baseline for those with HBV DNA <1000 IU/ml
Measured: 12 months
Number of patients with Incidence of seroconversion from Hepatitis B surface antigen to anti-Hepatitis B surface antibody
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionJun 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Composite Interceptive Med Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alben Sigamani, MD, Principal investigator, Narayana Hrudayalaya Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02899130
- Sponsor's protocol ID
- OI- 002- 2016
- Status last verified
- Dec 2017
- First submitted
- 8 Sep 2016
- Last updated
- 6 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiviral Effect of 3 Herbs in Chronic Inactive Carriers of Hepatitis B Virus. - A Randomized Placebo Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02899130
- Acronym / sponsor ID
- OI- 002- 2016
- Conditions
- Chronic Hepatitis B
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Composite Interceptive Med ScienceIndustry (pharma, biotech, devices)
- Study start
- Oct 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 14 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will study the effect of a polyherbal capsule in lowering the viral load of patients with chronic Hepatitis B infection and record the incidence of from Hepatitis B surface antigen elimination in 12 months
Detailed description
A placebo controlled randomised trial. 3 herbs that have proven effect on eliminating the virus and normalizing liver function will be given. Equally matched placebo (blinded) will be given randomly to patients. All parameters of hepatitis B infection will be compared between the randomized groups
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polyherbal | Experimental | Drug: PolyherbalCombination of 3 whole herbs in a capsule |
| Matching placebo | Placebo comparator | Drug: PlaceboSimilar looking inert capsules |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged above 18 years of age, with inactive chronic hepatitis B (HB) or immune tolerant phase, with or without dyslipidaemia and having all of the following
Key exclusion criteria (15 listed)
- Any one of the following
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PolyherbalAlso: Liver Kidney CareEach capsule contains 3 herbs. Phyllanthus niruri, Boerhaavia diffusa, picrorhiza kurroa | Drug | Polyherbal |
| PlaceboInactive compound that is similar looking as the intervention | Drug | Matching placebo |
Primary outcome
Number of patients with change in mean Hepatitis B Virus (HBV) DNA by at least 2log10 units from baseline at end of treatment for those with HBV DNA ≥ 1000 IU/ml.
Time frame: 12 months
2 secondary outcomes
Number of patients with change in hepatitis B surface antigen titers from baseline for those with HBV DNA <1000 IU/ml
Time frame: 12 months
Number of patients with Incidence of seroconversion from Hepatitis B surface antigen to anti-Hepatitis B surface antibody
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2017.
- Individual participant dataSharing planned: Undecided
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Chronic Hepatitis B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alben Sigamani, MD principal investigator
Narayana Hrudayalaya Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyherbal in people with Chronic Hepatitis B, run by Composite Interceptive Med Science at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alben Sigamani, MD (+91 8884431444, alben.sigamani.dr@nhhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with change in mean Hepatitis B Virus (HBV) DNA by at least 2log10 units from baseline at end of treatment for those with HBV DNA ≥ 1000 IU/ml. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2017.