| CTRI Number |
CTRI/2023/08/057144 [Registered on: 31/08/2023] Trial Registered Prospectively |
| Last Modified On: |
29/09/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical trial to evaluate the
hepatoprotective effect of Liv-Ever (Punarnava – Boerhavia
diffusa -tablet)
|
|
Scientific Title of Study
|
A pilot randomized controlled clinical trial to evaluate the
hepatoprotective effect of Liv-Ever (Punarnava – Boerhavia
diffusa -tablet) in patients with elevated liver enzyme panel
|
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PKHRF/IEC/55/05-23 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr J Hareendran Nair |
| Designation |
Managing Director and Founder |
| Affiliation |
Pankajakasthuri Herbal Research Foundation |
| Address |
Pankajakasthuri Herbal Research Foundation Pankajakasthuri Ayurveda Medical college Kattakkada Trivandrum
Thiruvananthapuram
KERALA
695572
India |
| Phone |
9447096201 |
| Fax |
|
| Email |
md@pkhil.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shan Sasidharan |
| Designation |
Director (Research and Development) |
| Affiliation |
Pankajakasthuri Herbal Research Foundation |
| Address |
Research and Development Department, Pankajakasthuri Herbal Research Foundation Pankajakasthuri Ayurveda Medical college
Thiruvananthapuram
KERALA
695572
India |
| Phone |
9188325339 |
| Fax |
|
| Email |
drshan@pkhil.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shan Sasidharan |
| Designation |
Director (Research and Development) |
| Affiliation |
Pankajakasthuri Herbal Research Foundation |
| Address |
Research and Development Department, Pankajakasthuri Herbal Research Foundation Pankajakasthuri Ayurveda Medical college
KERALA
695572
India |
| Phone |
9188325339 |
| Fax |
|
| Email |
drshan@pkhil.com |
|
|
Source of Monetary or Material Support
|
| Pankajakasthuri Ayurveda Medical College and PG centre
Killy
Kattakada
Trivandrum, 695572 |
|
|
Primary Sponsor
|
| Name |
University of Kerala |
| Address |
Department of Botany
Palayalam, Trivandrum, Kerala, India |
| Type of Sponsor |
Other [Govt University] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kasthuri Nair A |
Pankajakasthuri Ayurveda Medical College |
Room nO:1
Department of kayachikitsa, Killy, Kattakada
Kerala, India,
Thiruvananthapuram
KERALA |
8113851665
dr.kasthurinair@pkhil.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee of Pankajakasthuri Herbal Research Foundation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K70-K77||Diseases of liver. Ayurveda Condition: RAKTAVAHASROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: LIV-EVER (PUNARNAVA – BOERHAVIA DIFFUSA L -TABLET), Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 750(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Plain capsule | Plain capsule comprising of rice flour equivalent to the weight of LIV-EVER (PUNARNAVA – BOERHAVIA
DIFFUSA L -TABLET) |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Subjects of either gender with an age group between 18 - 70 years
Subjects having elevated liver enzymes panel due to multiple causes like obesity, hyper
triglyceridemia, drug induced liver disease etc.
Subjects with fluctuating liver enzyme panel due to unknown reasons.
Subjects who are willing to sign the informed consent form |
|
| ExclusionCriteria |
| Details |
Patients with chronic liver diseases
Pregnant and lactating women
Suspected malignant conditions. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the hepatoprotective effect of LIV-EVER (Punarnava – Boerhavia diffusa
L-tablet ) in patients with elevated liver enzyme panel
|
The assessments will be done on done on 0th
, 45th and 90th day and the results obtained will be
statistically analyzed to evaluate the hepatoprotective effect of trial drug in elevated liver enzyme
panels. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the additional therapeutic benefits of LIV-EVER (Punarnava – Boerhavia
diffusa L –tablet) in patients with elevated liver enzyme panel.
|
The assessments will be done on done on 0th
, 45th & 90th day & the results obtained will be
statistically analyzed to evaluate the hepatoprotective effect of trial drug in elevated liver enzyme
panels. |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
06/09/2023 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
nil |