| CTRI Number |
CTRI/2025/07/090303 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Curcuma zeodaria in Spasmodic Menstrual pain |
|
Scientific Title of Study
|
Efficacy of Zaranbad (Curcuma zeodaria) in Primary
Dysmenorrhoea: A Single Blind Randomized Controlled Trial. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 00 |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ghazala Hashmi |
| Designation |
Postgraduate Scholar |
| Affiliation |
State Takmeel-ut-Tib College and Hospital, Lucknow |
| Address |
Department of Niswan-wa-Qabalat
State Takmeel-ut-Tib College and Hospital,Aurangabad, Lucknow
Lucknow
UTTAR PRADESH
226012
India |
| Phone |
8700552910 |
| Fax |
|
| Email |
ghazalahashmi0107@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mariyam Roqaiya |
| Designation |
Lecturer |
| Affiliation |
State Takmeel-ut-Tib College and Hospital, Lucknow |
| Address |
Department of Niswan-wa-Qabalat
State Takmeel-ut-Tib College and Hospital,Aurangabad, Lucknow
Lucknow
UTTAR PRADESH
226002
India |
| Phone |
9632560839 |
| Fax |
|
| Email |
dr.mroqaiya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mariyam Roqaiya |
| Designation |
Lecturer |
| Affiliation |
State Takmeel-ut-Tib College and Hospital, Lucknow |
| Address |
Department of Niswan-wa-Qabalat
State Takmeel-ut-Tib College and Hospital,Aurangabad, Lucknow
Lucknow
UTTAR PRADESH
226002
India |
| Phone |
9632560839 |
| Fax |
|
| Email |
dr.mroqaiya@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Takmeel ut Tib College and Hospital Lucknow |
|
|
Primary Sponsor
|
| Name |
State Takmeel-ut-Tib College and Hospital, Lucknow |
| Address |
State Takmeel-ut-Tib College and Hospital,Aurangabad,226002 Lucknow |
| Type of Sponsor |
Government medical college |
|
|
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 Ghazala Hashmi |
OPD no. 111 niswan wa qabalat State Takmeel-ut-Tib College and Hospital, Lucknow |
State Takmeel-ut-Tib College and Hospital,Aurangabad,226002 Lucknow
Lucknow
UTTAR PRADESH |
08700552910
ghazalahashmi0107@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee |
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 |
Zaranbad (Curcuma zeodaria) |
Powder of Zaranbad (Curcuma zeodaria) is made after identification and purification
of drug. Then 1 gram (one masha) powder of Zaranbad is filled in capsules and given orally three times a day starting from day
one to day 3 of menstrual cycle. |
| Comparator Agent |
Mefenamic Acid |
Mefenamic acid will also be given orally 500 mg T.D.S in powder form filled in capsules and given orally three times a day starting from day one to day 3 of menstrual cycle. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
All unmarried and married women aged between 18 to 30 years of age with no
pelvic pathology.
Regular painful menstrual cycle graded by V.A.S scale (score more than grade
3) and V.R.S scale (score more than 0). |
|
| ExclusionCriteria |
| Details |
All unmarried and married women aged between 18 to 30 years of age with
pelvic pathology.
Pregnant females.
Lactating Females.
Females taking O.C.P. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in intensity of pain during menstrual cycle |
2months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in quality of life. |
2 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
14/07/2025 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 single blind randomised controlled trial for female patients suffering from primary dysmenorrhoea in which efficacy of Zaranbad ( Curcuma zeodaria ) will be evaluated and also comparing the effets the mention drug with standard drug mefenamic acid. Patients fulfilling inclusion criteria will be added to either test group or control group, patient will take research drug in form of capsule After the study duration effects of both test and control drugs will be compared. |