| CTRI Number |
CTRI/2024/05/066869 [Registered on: 06/05/2024] Trial Registered Prospectively |
| Last Modified On: |
03/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treatment of Painful menstruation with Ajwain khurasani |
|
Scientific Title of Study
|
Management of primary dysmenorrhea (usre tams) with Ajwain khurasani in comparison with Mefenamic acid |
| 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. M.N.Nasrina Begum |
| Designation |
PG Scholar, Department of QON,Govt.Nizamia Tibbi College |
| Affiliation |
Govt.Nizamia Tibbi College and Hospital |
| Address |
Room no :224,1st floor, PG Department of Obstetrics and Gynaecology,Govt. Nizamia Tibbi College and Hospital. Charminar.
Hyderabad
Hyderabad
TELANGANA
500002
India |
| Phone |
918142050158 |
| Fax |
|
| Email |
muhminasrina@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrShahzadi sultana |
| Designation |
Professor, Principal of Govt.Nizamia Tibbi College |
| Affiliation |
Govt.Nizamia Tibbi College and Hospital |
| Address |
Room no :224,1st floor, PG Department of Obstetrics and Gynaecology,Govt. Nizamia Tibbi College and Hospital. Charminar.
Hyderabad
Hyderabad
TELANGANA
500002
India |
| Phone |
9908624090 |
| Fax |
|
| Email |
drssntc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. M.N.Nasrina Begum |
| Designation |
PG Scholar,Department of QON, Govt.Nizamia Tibbi College |
| Affiliation |
Govt.Nizamia Tibbi College and Hospital |
| Address |
Room no :224,1st floor, PG Department,Govt. Nizamia Tibbi College and Hospital. Charminar.
Hyderabad
Hyderabad
TELANGANA
500002
India |
| Phone |
918142050158 |
| Fax |
|
| Email |
muhminasrina@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Nizamia Tibbi College and General Hospital,Charminar. Hyderabad. India.
500002 |
|
|
Primary Sponsor
|
| Name |
Government Nizamia Tibbi College and Hospital |
| Address |
Government Nizamia Tibbi College and Hospital,
Charminar
Hyderabad |
| Type of Sponsor |
Other [] |
|
|
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 |
| DrMNNasrina Begum |
Govt.Nizamia Tibbi College and Hospital |
PG Department of Obstetrics and Gynecology. Government Nizamia Tibbi College and Hospital Charminar.Hyderabad
Hyderabad
TELANGANA |
8142050158
muhminasrina@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Govt. Nizamia Tibbi College, Charminar, Hyderabad. Telegana State |
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 |
Ajwain khurasani
(Hyoscyamus niger) |
test group will be given joshanda(decoction) of ajwain khurasani 15ml bd with honey 2days before the onset of menstruation till 3rd day of the cycle |
| Comparator Agent |
Mefenamic acid |
Mefenamic acid 250mg bd (1st to 3rd day of cycle) |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
. Patient with regular periods
. Painful menstruation
Age group 13-30 years |
|
| ExclusionCriteria |
| Details |
pregnant women
use of intrauterine device/oral contraceptive pills
organic pelvic pathology
women with systemic illness
women with allergic/ hypersensitive to NSAIDs
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| visual analogue scale |
3 consecutive menstrual cycle |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
efficacy of test & control drug on associated symptoms
fatigue, headache, nausea & vomiting |
for 3 consecutive menstrual cycle |
|
|
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)
|
15/05/2024 |
| 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
|
Dysmenorrhoea literally means painful menstruation or cramping pain accompanying menstruation.Its classified into 2, primary and secondary. Primary dysmenorrhoea is widely prevalent more than 50% of teenagers and 30-50% of menstruating women suffer from various degree of discomfort. primary dysmenorrhoea is usually confined to adolescent girls. Pain begins few hour before or just with the onset of menstrution. Severity of pain usually lasts for few hours may extend 24hrs .the primary dysmenorrhoea is ine where there is no identifiable pelvic pathology. it is almost confined to ovulatory cycles. clinical features are the spasmodic pain confined to lower abdomen may radiate to back& medial aspect of thigh,nausea, vomiting, fatigue,diarrhoea, cold sweats,sleeplessness etc. |