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CTRI Number  CTRI/2024/07/070202 [Registered on: 08/07/2024] Trial Registered Prospectively
Last Modified On: 07/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani
Other (Specify) [Therapeutic]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical study of Unani Formulation in patients of pain during menstruation 
Scientific Title of Study   Clinical Study of Jawarish Qurtum and Arq e Badiyan in cases of Usr e Tams Ibtedayee primary dysmenorrhea A randomized single blind standard controlled Trial  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Faiza Furqan 
Designation  P G SCHOLAR 
Affiliation  Ajmal Khan Tibbiya College AMU Aligarh 
Address  Department of Amraz e Niswan wa Qabalat Ajmal Khan Tibbiya College AMU Aligarh

Aligarh
UTTAR PRADESH
202001
India 
Phone  6396666355  
Fax    
Email  faizafurqan7@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Fahmeeda Zeenat 
Designation  Assistant Professor 
Affiliation  Ajmal Khan Tibbiya College AMU Aligarh 
Address  Department of Amraz e Niswan wa Qabalat Ajmal Khan Tibbiya College AMU Aligarh

Aligarh
UTTAR PRADESH
202001
India 
Phone  8149536134  
Fax    
Email  fahmeedazeenat@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Fahmeeda Zeenat 
Designation  Assistant Professor 
Affiliation  Ajmal Khan Tibbiya College AMU Aligarh 
Address  Department of Amraz e Niswan wa Qabalat Ajmal Khan Tibbiya College AMU Aligarh

Aligarh
UTTAR PRADESH
202001
India 
Phone  8149536134  
Fax    
Email  fahmeedazeenat@gmail.com  
 
Source of Monetary or Material Support  
Department of Amraz E Niswan Wa Qabalat Ajmal Khan Tibbiya College AMU Aligarh Uttar Pradesh India 202001 
 
Primary Sponsor  
Name  Faiza Furqan 
Address  PG scholar Department of Amrza e Niswan wa Qabalat Ajmal Khan Tibbiya College AMU Aligarh India 202001 
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 
DR FAIZA FURQAN  Out-Patient Department and In-Patient Department  Department of Amraz-e-Niswan-Wa-Qabalat, Ajmal Khan Tibbiya College and Hospital Aligarh Muslim University
Aligarh
UTTAR PRADESH 		 6396666355

faizafurqan7@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Faculty of Unani Medicine, AMU, Aligarh  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  Jawarish Qurtum and Arq e badiyan   Route: oral route Dosage: 5 gm and 60ml twice a day Duration: seven days starting before 2 days of menstrual period up to 5th day of menses for three consecutive cycles. Jawarish Qurtum and arq e badiyan has the properties of analgesic antiinflammatory anti spasmodic deobstruent and antioxidant antidiabetic antispasmodic diuretic and emmenagogue properties 
Comparator Agent  Tab Mefenamic acid 250 mg  Tab mefenamic acid Route:oral route Dosage: 250mg twice a day after meal from beginning of menstruation Duration: Up to 3 days for three 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 maybe associated with one or more symptoms like Nausea vomiting diarrhea fatigue
Patients with regular and irregular menstrual cycle
Patients strictly with primary dysmenorrhea
Patients willing to take part in the study
 
 
ExclusionCriteria 
Details  Patients of age less than 12 and more than 35 years
hormonal and metabolic disorders any organic pelvic pathology
sensitivity to NSAID
Any systemic diseases like hypertension diabetes mellitus and sexually transmitted disease Patients with irregular cycle and flow
Patients with secondary dysmenorrhea
Lactating women
If the subject 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 cycle  
 
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 PBLAC score for menstrual blood loss  3 consecutive menstrual cycle  
 
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)   20/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  20/07/2024 
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 Yet Recruiting 
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  (sū’-i-mizāj)  resulting  in  difficult  orpainful  menstruation, so the drugs prescribed for the treatment of Usr e tams should be possessing the properties of muhallil, mudir e haiz, musakkin awjāh, mufattit sudad. a pharmacopoeial unani formulation Jawarish Qurtum and Arq e Badiyan is selected to study in patients of Usre Tams Ibtedayee. It contains 6 ingredients viz Maghz-e-Qurtum(Carthamus tinctorious) 24gm, Maghz-e-Badam Shireen(Prunus amygdalus) 24gm, Anisoon(Pimpinella anisum L.) 12gm, Bisfayej(Polypodium vulgareL.) 12gm, Asal 100gm, Mastagi(Pistacia lentiscus Linn.) 24gm. Araq e Badiyan(Feoniculum vulgare) also having the property of mudir e bol and digestive.

  
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