| CTRI Number |
CTRI/2024/06/069426 [Registered on: 24/06/2024] Trial Registered Prospectively |
| Last Modified On: |
30/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A bioavailability study to compare two Berberine formulations with two Berberine + Turmeric formulations in healthy adult human subjects. |
|
Scientific Title of Study
|
Single dose, crossover bioavailability study to compare the Formulation A Berberine 95 percent with Formulation B Berberine 95 percent plus Turmeric and Formulation C Berberine 70 percent with Formulation D Berberine 70 percent plus Turmeric in healthy adult human subjects. |
| Trial Acronym |
NIL |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| C3B04494; HWC/MSCD/PP/007/2024; Version: 01, Dated 03 Jun 24 |
Protocol Number |
| C3B04494; HWC/MSCD/PP/007/2024; Version: 02, Dated 11 Jul 24 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Simran Sethi MBBS |
| Designation |
Principal Investigator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off Sindhubhavan Rd,
Nr. Mann Party Plot Cross Road, Bodakdev.
Phone# 07966135601
Ahmadabad
GUJARAT
380054
India |
| Phone |
9825784942 |
| Fax |
|
| Email |
ssethi@cliantha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ranjita |
| Designation |
Scientific Manager |
| Affiliation |
Himalaya Wellness Company |
| Address |
Himalaya Wellness Company Room No 301, 3rd Floor Medical
Services and Clinical Development (R&D), Makali Tumkur Road,
Bangalore, KARNATAKA-56216
Bangalore
KARNATAKA
56216
India |
| Phone |
8067549920 |
| Fax |
|
| Email |
dr.ranjita.s@himalayawellness.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Soorya Narayan H |
| Designation |
Manager-Clinical Operations |
| Affiliation |
Himalaya Wellness Company |
| Address |
Himalaya Wellness Company Room No 301, 3rd Floor Medical
Services and Clinical Development (R&D), Makali Tumkur Road,
Bangalore, KARNATAKA-56216
Bangalore
KARNATAKA
56216
India |
| Phone |
8067549919 |
| Fax |
|
| Email |
dr.sooryanarayan.h@himalayawellness.com |
|
|
Source of Monetary or Material Support
|
| Cliantha Research, Corporate House 17, Sigma 1 Corporate House, BH. Rajpath Club, Off Sindhubhavan Road, Nr. Mann Party Plot Cross Road, Bodakdev, Ahmedabad-380054, Gujarat, India. |
| Himalaya Wellness Company Room No 301, 3rd Floor Medical Services and Clinical Development (R&D), Makali Tumkur Road, Bangalore, KARNATAKA-56216 India |
|
|
Primary Sponsor
|
| Name |
Himalaya Wellness Company |
| Address |
Room No 301, 3rd Floor Medical Services and Clinical Development (R&D), Makali Tumkur Road, Bangalore, KARNATAKA-56216 India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Simran Sethi |
Cliantha Research |
Consumer Research Department,
Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off Sindhubhavan Road,
Nr. Mann Party Plot Cross Road,
Bodakdev, Ahmedabad-380054, Gujarat.
Phone# 07966135601
Ahmadabad
GUJARAT |
9825784942
ssethi@cliantha.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| ACEAS – Independent Ethics Committee |
Approved |
| ACEAS – Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy male and/or non-pregnant, non-lactating female subjects |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Berberine 70% (Berberis aristata extract standardized to 70% Berberine) |
2 capsules (Dose: 250mg + 250mg)
Frequency: Period I - single dose; Wash out period - 7 Days; Period 2 - single dose
|
| Comparator Agent |
Berberine 70% + Turmeric (Berberis aristata extract standardized to 70% Berberine+ Standardized Turmeric extract containing 35% curcuminoids) |
2 capsules (Dose: 250mg + 125mg)
Frequency: Period I - single dose; Wash out period - 7 Days; Period 2 - single dose
|
| Intervention |
Berberine 95% (Berberis aristata extract standardized to 95% Berberine) |
2 capsules (Dose: 250mg)
Frequency: Period I - single dose; Wash out period - 7 Days; Period 2 - single dose
|
| Comparator Agent |
Berberine 95% + Turmeric (Berberis aristata extract standardized to 95% Berberine+ Standardized Turmeric extract containing 35% curcuminoids) |
2 capsules (Dose: 250mg)
Frequency: Period I - single dose; Wash out period - 7 Days; Period 2 - single dose
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1) Male and/or non-pregnant, non-lactating female subjects with BMI from 18.5 to 30.0 kg/m2 (both inclusive).
2) Healthy subjects according to medical history, screening assessments (lab and medical examinations).
3) Subjects willing to provide written informed consent to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1) Have significant diseases or clinically significant abnormal findings during screening [medical history, physical examination (clinical examination), laboratory evaluations, ECG recordings, gynaecological history and present complaints (for female volunteers)].
2) Subjects having foods containing high concentrations of turmeric or turmeric rich foods within the 14 days prior to drug administration.
3) Subjects with positive serology for HIV and HbsAg.
4) Subjects with usage of berberine supplements.
5) History or evidence of drug dependence or of alcoholism or of moderate alcohol use.
6) Smoker who smokes 10 or more cigarettes per day or 20 or more biddies per day or those who cannot refrain from smoking during the study period.
7) Volunteer who has donated blood or loss of blood 50 ml to 100 ml within 30 days or 101 ml to 200 ml within 60 days or more than 200 ml within 90 days (excluding volume drawn at screening for this study) prior to first dose of study medication, whichever is greater.
8) Intolerance to venipuncture
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the oral bioavailability between Formulations A and B and between Formulations C and D by analyzing plasma samples using LC-MS/MS method specific for the determination of berberine. |
Pre-dose (0.0 hour), 0.25, 0.50, 1.00, 2.00, 4.00 and 8.00 hours (within +2 mins of schedule time) post dose for period 1 and 2. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor the safety and tolerability of the subjects. |
Pre-dose (0.0 hour), 0.25, 0.50, 1.00, 2.00, 4.00 and 8.00 hours (within plus 2 mins of scheduled time) post dose for period 1 and 2 |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
11/07/2024 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This
is an open label, randomized, comparative, two-period, four-treatment,
two-sequence, crossover, balanced, single dose oral bioavailability study to
compare the [Formulation A: Berberine 95% with Formulation B: Berberine 95% +
Turmeric] and [Formulation C: Berberine 70% with Formulation D: Berberine 70% +
Turmeric] in healthy adult, human subjects. Total
expected duration of the clinical part is 09 Days from the day of check-in of
first period. The
following PK parameters will be measured: Cmax, AUCt, AUCi, Tmax, Kel,
AUC_%Extrap_obs and tHalf. |