| CTRI Number |
CTRI/2025/04/085257 [Registered on: 21/04/2025] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical study to evaluate the effect of a test product (Lactic acid based Probiotic tablet) for Treatment of Iron Deficiency Anemia in participants with Menorrhagia and Premenstrual Syndrome. |
|
Scientific Title of Study
|
A Multi-centre, Randomized, Double-blind, Two-arm, Comparative, Placebo-controlled Study to Evaluate the Efficacy and Safety of Lactic acid based Probiotic tablet for Treatment of Iron Deficiency Anemia in participants with Menorrhagia and Premenstrual Syndrome. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C3B05552; Version: 01, Dated 12 Mar 25 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Parth Joshi |
| Designation |
Overall Trial Coordinator |
| Affiliation |
Cliantha Research |
| Address |
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.
Ahmadabad
GUJARAT
380054
India |
| Phone |
8000085049 |
| Fax |
|
| Email |
pjoshi@cliantha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Simran Sethi |
| Designation |
Director – Consumer Research |
| Affiliation |
Cliantha Research |
| Address |
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.
Ahmadabad
GUJARAT
380054
India |
| Phone |
9825784942 |
| Fax |
|
| Email |
ssethi@cliantha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Simran Sethi |
| Designation |
Director – Consumer Research |
| Affiliation |
Cliantha Research |
| Address |
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.
GUJARAT
380054
India |
| Phone |
9825784942 |
| Fax |
|
| Email |
ssethi@cliantha.com |
|
|
Source of Monetary or Material Support
|
| CLAPS Industries Pvt. Ltd. B-1202, Infinity Tower, Beside Hotel Ramada, 60 Feet Road, Prahladnagar, Ahmedabad - Pin 380015, Gujarat, India |
|
|
Primary Sponsor
|
| Name |
CLAPS Industries Pvt. Ltd. |
| Address |
B-1202, Infinity Tower,
Beside Hotel Ramada,
60 Feet Road, Prahladnagar,
Ahmedabad - Pin 380015, Gujarat, India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Neetu Verma |
Atharva multispecialty hospital & Research Centre (Site 01) |
H-4/Comm-2, Construction Div-21, UP Avas Vikas Parishad, IIM Road, Sector-E Dubagga, Lucknow-226003, UP, India
Lucknow
UTTAR PRADESH |
8535024005
Hospital.atharva@gmail.com |
| Dr Tushar Shah |
Navneet Memorial Hospital "Sushrusha” (Site 03) |
Opp. Sardar Patel seva samaj hall,
Navarangpura telephone exchange, Off C.G. Road, Ahemdabad-380006, Gujarat, India
Ahmadabad
GUJARAT |
9825007667
Drtusharshah74@gmail.com |
| Dr Vineet Shukla |
Tender Palm Hospital (Site 02) |
Sector-7, Gomtinagar Extension Amar Shaheed Path, Lucknow Uttar Pradesh India 226001
Lucknow
UTTAR PRADESH |
7905304034
Vineetshukla38@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Ethics Committee of Navneet Memorial |
Submittted/Under Review |
| Independent Ethics Committee Narayana Diagnostics |
Approved |
| Institutional Ethics committee for Atharva multispecialty hospital & Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D509||Iron deficiency anemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo product i.e. Tablet |
Two tablets (one tablet in the morning and one tablet in the evening) will be consumed with water after meals till the end of the study |
| Intervention |
Test product i.e. Tablet |
Two tablets (one tablet in the morning and one tablet in the evening) will be consumed with water after meals till the end of the study |
|
|
Inclusion Criteria
|
| Age From |
11.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Age:
a. Adolescent female participants who have reached Menarche.
OR
b. Pre-menopausal female participants.
2. Participants with diagnosis of Iron Deficiency Anemia (IDA) as confirmed by low Hb levels and low serum ferritin levels as per PI’s discretion.
3. Participants with Menorrhagia.
OR
Participants with Premenstrual syndrome
4. Participants having good general health as determined by the Investigator on the basis of medical history and physical examination.
5. Participants willing to consume test product throughout the study period as instructed.
6. Participants should be willing and able to follow the study protocol to participate in the study. |
|
| ExclusionCriteria |
| Details |
1. Pregnant or breastfeeding or planning pregnancy during the study period.
2. Participants with severe anemia, defined as hemoglobin levels less than 8 g/dL.
3. Participants with history of acute peptic ulcer, severe GERD and/or ulcer complications or other functional GI disorder.
4. Participants with clinically suspected uterine leiomyomas, adenomyosis, or polyps.
5. Participants with clinically suspected malignancy of the uterus or cervix.
6. Participants with history of pregnancy-related conditions such as miscarriages, abortions, intrauterine growth restriction (IUGR), etc.
7. Participants having any chronic illness or health condition such as hyperthyroidism or hypothyroidism, diabetes, Peripheral Artery Disease, CKD, previous major surgery, HIV, hepatitis etc. that can interfere with the outcome of the study.
8. Participants suffering from diseases Alzheimer’s, Parkinson’s disease, and dementia. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of CBC and serum ferritin levels |
Screening Visit (i.e., within 07 days of enrollment) to Day 60 (+ 02 Days), Day 90 (+ 02 Days) and Day 105 (+ 02 Days) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of Menorrhagia Symptoms |
Day 00 (i.e., baseline) to Day 60 (plus 02 Days), Day 90 (plus 02 Days) and Day 105 (plus 02 Days) |
| Assessment of Menstrual cramp pain |
Day 00 (i.e., baseline) to Day 60 (plus 02 Days), Day 90 (plus 02 Days) and Day 105 (plus 02 Days) |
| Assessment of Fatigue Levels |
Day 00 (i.e., baseline) to Day 60 (plus 02 Days), Day 90 (plus 02 Days) and Day 105 (plus 02 Days) |
| Assessment of Mood Swings |
Day 00 (i.e., baseline) to Day 60 (plus 02 Days), Day 90 (plus 02 Days) and Day 105 (plus 02 Days) |
| Assessment of Overall Quality of Life |
Day 00 (i.e., baseline) and Day 105 (plus 02 Days) |
| Assessment of Serum Iron Levels, Total Iron-Binding Capacity (TIBC) and Transferrin Saturation |
Screening Visit (i.e., within 07 days of enrollment) and Day 105 (plus 02 Days) |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
19/05/2025 |
| 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="0"
Months="3"
Days="15" |
|
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 is a Multi-centre, Randomized,
Double-blind, Two-arm, Comparative, Placebo-controlled Study to Evaluate the
Efficacy and Safety of Lactic acid based Probiotic tablet for Treatment of Iron
Deficiency Anemia in participants with Menorrhagia and Premenstrual Syndrome.
The potential Participants will be
screened as per the inclusion and exclusion criteria only after obtaining
written informed consent from the Participants.
All eligible Participants will
undergo laboratory evaluation (blood tests) and evaluation using
different scales/questionnaires. Safety will be assessed throughout the study
by monitoring vital signs and adverse events. |