| CTRI Number |
CTRI/2025/04/083924 [Registered on: 02/04/2025] Trial Registered Prospectively |
| Last Modified On: |
02/04/2025 |
| 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 Karafs (Apium graveolens, Linn) and Hulba (Trigonella foenum graecum, Linn) in the patients having pain during menstruation (Dysmenorrhoea) |
|
Scientific Title of Study
|
Efficacy and Safety of Karafs (Apium graveolens Linn) and Hulba (Trigonella foenum graecum Linn) in the management of Usr-e-Tams Ibtedayee (Primary Dysmenorrhoea):A randomized single blind controlled study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHAMMA PARVEEN |
| Designation |
PG Scholar |
| Affiliation |
ALIGARH MUSLIM UNIVERSITY ALIGARH |
| Address |
DEPARTMENT OF NISWAN WA QABALAT AJMAL KHAN TIBBIYA COLLEGE ALIGARH MUSLIM UNIVERSITY ALIGARH
Aligarh UTTAR PRADESH 202001 India |
| Phone |
8578974474 |
| Fax |
|
| Email |
shamma21198@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
PROF SUBOOHI MUSTAFA |
| Designation |
PROFESSOR |
| Affiliation |
ALIGARH MUSLIM UNIVERSITY ALIGARH |
| Address |
DEPARTMENT OF NISWAN WA QABALAT AJMAL KHAN TIBBIYA COLLEGE ALIGARH MUSLIM UNIVERSITY ALIGARH
Aligarh UTTAR PRADESH 202001 India |
| Phone |
9411413788 |
| Fax |
|
| Email |
drsuboohi_m@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
PROF SUBOOHI MUSTAFA |
| Designation |
PROFESSOR |
| Affiliation |
ALIGARH MUSLIM UNIVERSITY ALIGARH |
| Address |
DEPARTMENT OF NISWAN WA QABALAT AJMAL KHAN TIBBIYA COLLEGE ALIGARH MUSLIM UNIVERSITY ALIGARH
Aligarh UTTAR PRADESH 202001 India |
| Phone |
9411413788 |
| Fax |
|
| Email |
drsuboohi_m@yahoo.com |
|
|
Source of Monetary or Material Support
|
| ALIGARH MUSLIM UNIVERSITY ALIGARH |
|
|
Primary Sponsor
|
| Name |
SHAMMA PARVEEN |
| Address |
PG SCHOLAR DEPARTMENT OF NISWAN WA QABALAT AJMAL KHAN TIBBIYA COLLEGE AND HOSPITAL ALIGARH MUSLIM UNIVERSITY ALIGARH |
| 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 |
| SHAMMA PARVEEN |
AJMAL KHAN TIBBIYA COLLEGE, AMU ALIGARH |
OPD AND IPD OF DEPARTMENT OF NISWAN WA QABALAT, AJMAL KHAN TIBBIYA COLLEGE, AMU, ALIGARH Aligarh UTTAR PRADESH |
8578974474
shamma21198@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL 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 |
DECOCTION OF TUKHME KARAFS AND TUKHME HULBA |
DECOCTION OF TUKHME KARAFS 5gm AND TUKHME HULBA 5gm GIVEN ORALLY TWICE DAILY FOR 2 DAYS BEFORE THE ONSET OF MENSTRUAL CYCLE AND CONTINUED TILL THE 3rd DAY OF THE CYCLE FOR CONSECUTIVE 3 CYCLES. TUKHME KARAFS AND TUKHME HULBA HAS THE PROPERTIES OF ANALGESIC ANTI INFLAMMATORY ANTI SPASMODIC EMMENOGOGUE DEOBSTRUANT AND DIURETIC. |
| Comparator Agent |
TABLATE MEFENAMIC ACID 500mg |
TABLATE MEFENAMIC ACID 500mg GIVEN ORALLY TWICE DAILY FROM BEGINNING OF MENSTRATION FOR 3 TO 5 DAYS FOR 3 CONSECUTIVE MENSTRUAL CYCLES. IT IS NSAID USE TO TREAT MILD TO MODERATE PAIN. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
PATIENTS OF AGE GROUP 12-35 YEARS, PATIENTS WITH REGULAR PAINFUL MENSTRUATION MAY BE ASSOCIATED WITH ONE OR MORE SYMPTOMS LIKE NAUSEA VOMITING DIARRHEA FATIGUE, STRICTLY PRIMARY DYSMENORRHEA, PATIENTS WILLING TO TAKE PART IN THE STUDY. |
|
| ExclusionCriteria |
| Details |
HORMONAL AND METABOLIC DISORDERS, ANY ORGANIC PELVIC PATHOLOGY, SENSITIVITY TO NSAIDS, ANY SYSTEMIC DISEASES LIKE HYPERTENSION DIABETES MELLITUS, PATIENTS WITH SECONDARY DYSMENORRHEA, LACTATING WOMEN, IF THE PATIENT NOT WILLING TO CONTINUE |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| DECREASE IN VAS AND VMSS SCORES FOR PAIN INTENSITY |
3 CONSECUTIVE MENSTRUAL CYCLES |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| IMPROVEMENT IN THE QUALITY OF LIFE DETERMINED BY SF 36 HEALTH SURVEY QUESTIONNAIRE, REDUCTION IN THE DURATION OF PAIN ASSOCIATED SYSTEMIC SYMPTOMS AND PBAC SCORE FOR MENSTRUAL BLOOD LOSS |
3 CONSECUTIVE MENSTRUAL CYCLES |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
14/04/2025 |
| 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)
|
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
|
DYSMENORRHEA IS A PAINFUL MENSTRUATION OF SUFFICIENT MAGNITUDE SO AS TO INCAPACITATE DAY TODAY ACTIVITY. IT IS PAINFUL AND CRAMPING SENSATION IN THE LOWER ABDOMEN OFTEN ACCOMPANIED BY BIOLOGICAL SYMPTOMS SUCH AS FATIGUE AND DIZZINESS OCCURRING JUST BEFORE OR DURING THE MENSES. THE INCIDENCE OF PRIMARY DYSMENORRHEA OF SUFFICIENT MAGNITUDE WITH INCAPACITATION IS ABOUT 15-20%. IT IS A VERY COMMON COMPLAINT, EXPERIENCED BY 45-95% OF WOMEN OF REPRODUCTIVE AGE GROUP. DYSMENORRHEA IS OF TWO TYPES: PRIMARY DYSMENORRHOEA (USR-E-TAMS IBTEDAYEE) IS A COMMON GYNECOLOGICAL COMPLAIN REFERS TO THE OCCURRENCE OF PAINFUL MENSTRUAL CRAMPS OF UTERINE ORIGIN DURING MENSTRUATION IN THE ABSENCE OF AN IDENTIFIABLE PATHOLOGICAL LESION. PRIMARY DYSMENORRHEA USUALLY APPEARS WITHIN 1-2 YEARS OF MENARCHE, WHEN OVULATORY CYCLES ARE ESTABLISHED. THE DISORDER AFFECTS THE YOUNGER WOMEN BUT MAY PERSIST INTO THE 40S. IT AFFECTS MORE THAN 50% OF POST PUBESCENT WOMEN IN THE AGE GROUPS OF 18-25 YEARS. IT IS COMMON IN ADOLESCENT AND CHARACTERIZED BY SPASMODIC PAIN BEGINNING WITH ONSET OF MENSTRUATION AND LASTING 12-24 HRS. IN CLASSICAL UNANI LITERATURE, USR-E-TAMS HAS BEEN DESCRIBED AS DARD AL-RAHIM OR AUJA’-E- RAHEM. THE PAIN USUALLY OCCURS IN THE UTERUS AND SPREADS TO THE SURROUNDING AREAS. IT HAS BEEN MENTIONED THAT ANY OBSTRUCTION TO THE FLOW OF MENSTRUAL BLOOD ALTERS THE TEMPERAMENT (SU-I-MIZAJ) RESULTING IN DIFFICULT OR PAINFUL MENSTRUATION, SO THE DRUGS PRESCRIBED FOR THE TREATMENT OF USR E TAMS SHOULD BE POSSESSING THE PROPERTIES OF MUHALLIL, MUDIR E HAIZ, MUSAKKIN AWJAH, MUFATTIT SUDAD. THE PRESENT FORMULA OF DECOCTION OF TUKHME KARAFS (APIUM GRAVEOLENS, LINN) AND TUKHME HULBA (TRIGONELLA FOENUM GRAECUM, LINN) TAKEN FOR THE PROSPECTIVE STUDY IS ALREADY MENTIONED FOR THE TREATMENT OF USR E TAMS IN UNANI PHARMACOPOEIAL BOOK AKSEER-E-AZAM. |