| CTRI Number |
CTRI/2025/03/081600 [Registered on: 04/03/2025] Trial Registered Prospectively |
| Last Modified On: |
06/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Other |
|
Public Title of Study
|
The benifecial role of Oral Probiotics Supplementation in Women of Reproductive Age Group facing excessive pain during menses |
|
Scientific Title of Study
|
The Impact of Probiotics in Relieving Symptoms of Primary Dysmenorrhea: A Randomized Single Blind Placebo Controlled Trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anil Kumar |
| Designation |
Associate Professor |
| Affiliation |
BRD Medical College, Gorakhpur |
| Address |
3rd Floor, Department of Pharmacology, BRD Medical College, Gorakhpur, Uttar Pradesh- 273013, India
Gorakhpur
UTTAR PRADESH
273013
India |
| Phone |
8303060884 |
| Fax |
|
| Email |
dranilk194@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil Kumar |
| Designation |
Associate Professor |
| Affiliation |
BRD Medical College, Gorakhpur |
| Address |
3rd Floor, Department of Pharmacology, BRD Medical College, Gorakhpur, Uttar Pradesh- 273013, India
UTTAR PRADESH
273013
India |
| Phone |
8303060884 |
| Fax |
|
| Email |
dranilk194@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neelu Bharti |
| Designation |
Junior Resident |
| Affiliation |
BRD Medical College, Gorakhpur |
| Address |
3rd Floor, Department of Pharmacology, BRD Medical College, Gorakhpur, Uttar Pradesh- 273013. India
Gorakhpur
UTTAR PRADESH
273013
India |
| Phone |
7985690200 |
| Fax |
|
| Email |
omnovaom@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pharmacology, BRD Medical College, Gorakhpur, Uttar Pradesh- 273013, India |
|
|
Primary Sponsor
|
| Name |
Dr Neelu Bharti |
| Address |
Department of Pharmacology, BRD Medical College, Gorakhpur, Uttar Pradesh- 273013, India |
| 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 Neelu Bharti |
BRD Medical College |
Department of Pharmacology, 3rd floor, BRD Medical College
Gorakhpur
UTTAR PRADESH |
7985690200
omnovaom@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional human ethical commitee, BRD Medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R50-R69||General symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
oral sugar capsule 1gm |
1 capsule with 1 gm sugar |
| Intervention |
Probiotic capsule 1 OD |
1 capsule OD for one month |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1)Female of age 15-35 years
2)Diagnosed with primary dysmenorrhea
3)Moderate to severe pain during menses on visual analogue scale
4)No H/O any other gynecological disoerder |
|
| ExclusionCriteria |
| Details |
1)Pregnancy
2)Use of antibiotics within 3 Months prior to study
3)Current use of OCPs
4)Chronic gastrointestinal disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of life |
Baseline, 3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse drug reaction of drugs |
Every 3 months for 6 months |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
15/03/2025 |
| 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
Modification(s)
|
NJPT-Vol 2, Supplement 1, 2024 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is aiming to evaluate the impact and effectiveness of oral probiotics 1capsule OD for 1 month to 3 months in relieving excessive pain during menses. The study is randomized single blind placebo-controlled trial. it shows beneficial effects of probiotics for reproductive age group females suffering from primary dysmenorrhea by reducing painkiller (NSAIDS) intake frequency during menses. |