| CTRI Number |
CTRI/2025/05/086338 [Registered on: 05/05/2025] Trial Registered Prospectively |
| Last Modified On: |
31/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Study to Check if Ginger Extract Granules are Safe and Helpful for Women with Menstrual Pain |
|
Scientific Title of Study
|
A Double-Blind, Placebo-Controlled, Multi-Centered Phase III Clinical Study to Evaluate the Safety and Efficacy of Ginger Extract Granules in Subjects with Primary Dysmenorrhea. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CTSRS/2501 Version No 1.0 Dated 14 Apr 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr K Hemalatha |
| Designation |
Principal Investigator |
| Affiliation |
Udhbhava Hospital |
| Address |
Room No.5, Ground floor, #114, 100 Feet Ring Road,
Banashankari 3rd Stage, Bangalore
Bangalore
KARNATAKA
560085
India |
| Phone |
06364467752 |
| Fax |
|
| Email |
drhemalatha.udhbhava@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr. K. Hemalatha |
| Designation |
Principal Investigator |
| Affiliation |
Udhbhava Hospital |
| Address |
Room No.5, Ground Floor,
#114, 100 Feet Ring Road,
Banashankari 3rd Stage
Bangalore
KARNATAKA
560085
India |
| Phone |
06364467752 |
| Fax |
|
| Email |
drhemalatha.udhbhava@gmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr. Nehru Sai Suresh |
| Designation |
Associate Manager |
| Affiliation |
India Glycols Ltd. |
| Address |
Clinical Research/Operations-R&D
Plot 2-5, Pharmacity,
Selaqui,
Dehradun
Dehradun
UTTARANCHAL
248197
India |
| Phone |
9553659653 |
| Fax |
|
| Email |
Nehru.S.Suresh@indiaglycols.com |
|
|
Source of Monetary or Material Support
|
| India Glycols Ltd. PLOT 2-5, Pharma City
Selaqui-248197, Dehradun-Uttarakhand, India
|
|
|
Primary Sponsor
|
| Name |
India Glycols Ltd. |
| Address |
PLOT 2-5, Pharma City
Selaqui-248197, Dehradun-Uttarakhand, India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Urvashi P Bhatara |
Rajalakshmi Hospital and Research Center |
Room No. 2, Ground Floor, #21/1 Lakshmipura Main Road, Vidyaranyapura Post,
Bangalore-560097
Bangalore
KARNATAKA |
9986046906
drurvashibhatara@gmail.com |
| Dr Palli Sudhir Babu |
SVS Medical College and Hospital |
Department of OBG, Room Number-1, SVS Medical College and Hospital Yenugonda, Mahabubnagar-509002
Mahbubnagar
TELANGANA |
9000007335
magadhira@gmail.com |
| Dr K Hemalatha |
Udhbhava Hospital |
Room No.5, Ground floor, #114, 100 Feet Ring Road,
Banashankari 3rd Stage,
Bangalore – 560085
Bangalore
KARNATAKA |
6364467752
drhemalatha.udhbhava@gmail.com |
| Dr Vanajakshi |
Unique Healthcare Centre |
No:1761, Ground Floor,
Navrang Circle,
Dr. Rajkumar Road, 2nd Block,
Rajajinagar,
Bangalore – 560010
Bangalore
KARNATAKA |
9901355800
uniquerajajinagar@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Pranav Diabetes Center Ethics Committee |
Approved |
| Pranav Diabetes Center Ethics Committee |
Approved |
| Pranav Diabetes Center Ethics Committee |
Approved |
| SVS Medical College Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N944||Primary dysmenorrhea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ginger extract granules |
The intervention is Ginger Extract Granules, 100 mg, administered orally twice daily (morning and evening) after food for 90 days (3 months) in female subjects aged 20 to 30 years with primary dysmenorrhea. |
| Comparator Agent |
Placebo |
The comparator consists of placebo (100 mg) administered orally twice daily (morning and evening) after food for 90 days (3 months) in female subjects aged 20 to 30 years with primary dysmenorrhea. In this double-blind, placebo-controlled study, subjects will be randomized in a 1:1 ratio to either the ginger extract granules intervention group or the placebo comparator group, with safety assessments conducted regularly |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
1. Healthy educated metro women aged greater than or equal to 20 and less than or equal to 30 years.
2. Married women with regular sexual life without childbirth or any abortion.
3. Having primary dysmenorrhea symptoms continuously for at least 2 menstrual cycles months prior to the study screening.
4. Non-allergic to test item.
5. Subjects having not more than one episode of severe dysmenorrhea in a given menstrual cycle.
6. Subjects with self-reported history of primary dysmenorrhea with moderate (VAS Score greater than or equal to 4 to less than or equal to 6) menstrual cramp pain (based on the 10-point Visual Analogue Scale) occurring during four of the past six menstrual cycles.
7. Desirability and comfortability to use menstrual cups throughout the study.
8. Subjects willing to participate in the study.
9. Subjects who are willing to sign the informed consent and participate in the study.
10. Subjects willing to use only condoms as contraceptive method.
|
|
| ExclusionCriteria |
| Details |
1. Devoid of secondary dysmenorrhea and other fertility-related issues.
2. Subject has a current or past history of severe gastritis, gastrointestinal bleeding or ulceration.
3. Subject has a current or past history of the urinary tract infection.
4. Positive pregnancy test or breastfeeding at screening and prior to dosing.
5. Subjects with previous history of abortion.
6. Subjects with aversion to sexual life or sexual partner.
7. Subjects with hypoactive sexual desire disorder.
8. Subjects with spouse living in different area/ city.
9. Subjects who are single house wives.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in dysmenorrhea pain as measured by a Visual Analogue Scale (VAS) and Working Ability, Location, Intensity, Days of Pain, Dysmenorrhea (WaLIDD) scale at menstrual cycle -2, -1, 1, 2, and 3 relative to dosing.
Also, number of subjects with reduction in the dysmenorrhea pain will be documented. |
1. Baseline (Pre-treatment)
2. 4 weeks after the start of dosing (approximately Day 1 of the 2nd menstrual cycle)
3. 8 weeks after the start of dosing (approximately Day 1 of the 3rd menstrual cycle)
4. 12 weeks after the start of dosing (approximately Day 1 of the 4th menstrual cycle) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Change in physical, mood, & behavioral symptoms.
2.Improvement in female sexual function.
3.Improvement in sexual quality of life.
4.Improvement in general wellness.
5.Menstrual fluid flow evaluation.
6.Adverse events & abnormal lab findings.
|
1. Baseline (Pre-treatment)
2. 4 weeks after the start of dosing (approximately Day 1 of the 2nd menstrual cycle)
3. 8 weeks after the start of dosing (approximately Day 1 of the 3rd menstrual cycle)
4. 12 weeks after the start of dosing (approximately Day 1 of the 4th menstrual cycle) |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
13/05/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 study aims to evaluate the safety and efficacy of ginger extract granules compared to placebo in female subjects aged 20-30 years diagnosed with primary dysmenorrhea. It is a double-blind, placebo-controlled, multi-centered clinical trial involving 100 subjects. Participants will be randomized in a 1:1 ratio to receive either ginger extract granules or placebo twice daily for 90 days. The primary objective is to assess the impact on menstrual pain severity, with secondary objectives focusing on change in menstrual symptoms, improvement in female sexual function, quality of life and general wellness, monitoring of adverse events and abnormal laboratory data. The study also evaluates the changes in the Subject and Physician Global Assessment scale scores. |