| CTRI Number |
CTRI/2025/07/091246 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
19/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Hibiscus Extract on the growth of Probiotic bacteria |
|
Scientific Title of Study
|
Assessment of the impact of Hibiscus Extract as Probiotics |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anjali Singh |
| Designation |
Student |
| Affiliation |
Dr. BMN College of Home Science |
| Address |
Dr BMN College of Home Science Department of Clinical Nutrition and Dietetics 338 R A Kidwai Marg Matunga East Mumbai Maharashtra
Mumbai (Suburban)
MAHARASHTRA
400019
India |
| Phone |
8104890391 |
| Fax |
|
| Email |
anjsingh1107@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rupali Sengupta |
| Designation |
Head of the Department |
| Affiliation |
Dr. BMN College of Home Science |
| Address |
Dr BMN College of Home Science Department of Clinical Nutrition and Dietetics 338 R A Kidwai Marg Matunga East Mumbai Maharashtra
Mumbai (Suburban)
MAHARASHTRA
400019
India |
| Phone |
9892415789 |
| Fax |
|
| Email |
rupali@bmncollege.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rupali Sengupta |
| Designation |
Head of the Department |
| Affiliation |
Dr. BMN College of Home Science |
| Address |
Dr BMN College of Home Science Department of Clinical Nutrition and Dietetics 338 R A Kidwai Marg Matunga East Mumbai Maharashtra
Dr BMN College of Home Science Department of Clinical Nutrition and Dietetics 338 R A Kidwai Marg Matunga East Mumbai Maharashtra
Mumbai (Suburban)
MAHARASHTRA
400019
India |
| Phone |
9892415789 |
| Fax |
|
| Email |
rupali@bmncollege.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Anjali Singh |
| Address |
Dr BMN College of Home Science Department of Clinical Nutrition and Dietetics 338 R A Kidwai Marg Matunga East Mumbai Maharashtra |
| Type of Sponsor |
Other [Self] |
|
|
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 Rupali Sengupta |
Dr. BMN College of Home Science |
Dr. BMN College of Home Science, Department of Clinical Nutrition and Dietetics 338 R.A. Kidwai Marg Matunga East Mumbai Maharashtra 400019
Mumbai (Suburban)
MAHARASHTRA |
9892415789
rupali@bmncollege.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seva mandal educational society institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Since it is a laboratory study health condition is not applicable |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy individuals aged 18-40 years.
2. No chronic gastrointestinal diseases.
3. No history of antibiotic use in the past 4 weeks. |
|
| ExclusionCriteria |
| Details |
1. Pregnant or lactating woman.
2. Individuals with known sensitivity to Hibiscus.
3. Those with recent gastrointestinal disturbances or treatments that can skew the results. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To evaluate the effect of Hibiscus sabdariffa extract on the growth and viability of Lactobacillus acidophilus by comparing colony-forming units (CFU/mL) in media with and without Hibiscus supplementation |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To determine the optimal concentration of Hibiscus extract that supports the highest growth and survival of Lactobacillus acidophilus under in vitro conditions |
2 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/08/2025 |
| 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) |
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 in-vitro laboratory study aims to evaluate the effect of Hibiscus sabdariffa extract on the growth and survival of Lactobacillus acidophilus. The probiotic strain will be cultured in De Man Rogosa and Sharpe media with and without Hibiscus extract supplementation. The growth will be assessed by colony-forming unit counts using the spread plate method. Observations will be recorded on Day 0, 15, 30, 45, and 60. The study seeks to identify the optimal concentration of Hibiscus extract that supports probiotic viability. Results will help determine the potential of Hibiscus as a functional ingredient in probiotic formulations to enhance gut health. |