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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.


 
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