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CTRI Number  CTRI/2023/07/055235 [Registered on: 14/07/2023] Trial Registered Prospectively
Last Modified On: 13/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Efficacy evaluation of Unani formulation in pain during menstrual cycle. 
Scientific Title of Study   Efficacy and safety of Asaroon in primary dysmenorrhea in comparison with mefenamic acid: A randomized double 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  Dr Hina Bano Nurullah 
Designation  PG Scholar 
Affiliation  Luqman Unani Medical College Hospital and Research Centre 
Address  Department of Ilmul Qabalat wa Amraze Niswan, Luqman Unani Medical College Hospital and Research Centre 12 Naubagh Vijaypur Karnataka

Bijapur
KARNATAKA
586101
India 
Phone  7218871491  
Fax    
Email  drhinanurullah@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mohd Aqil Quadri 
Designation  Professor 
Affiliation  Luqman Unani Medical College Hospital and Research Centre 
Address  Department of Ilmul Qabalat Wa Amraze Niswan, Luqman Unani Medical College Hospital and Research Centre 12 Naubag Vijaypur Karnataka

Bijapur
KARNATAKA
586101
India 
Phone  9849090182  
Fax    
Email  aqilquadri@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nikhat Kausar Inamdar 
Designation  Assistant Professor 
Affiliation  Luqman Unani Medical College Hospital and Research Centre 
Address  Department of Ilmul Qabalat Wa Amraze Niswan, Luqman Unani Medical College Hospital and Research Centre 12 Naubag Vijaypur Karnataka

Bijapur
KARNATAKA
586101
India 
Phone  7019276469  
Fax    
Email  nikhatinamdar72@gmail.com  
 
Source of Monetary or Material Support  
Luqman Unani Medical College Hospital And Research Centre, 12, Naubagh, Bijapur, Karnataka, India, 586101 
 
Primary Sponsor  
Name  Luqman Unani Medical College Hospital and Research Centre 
Address  Luqman Unani Medical College Hospital and Research Centre 12 Naubag Vijaypur Karnataka 
Type of Sponsor  Private medical college 
 
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 Hina Bano Nurullah  Luqman Unani Medical College Hospital and Research Centre  PG-OPD No. 2, Ground Floor, Dept. of Ilmul Qabala wa Amraz-e-Niswan, Luqman Unani Medical College Hospital and Research Centre, 12 Naubagh, Bijapur, Karnataka-586101
Bijapur
KARNATAKA 
7218871491

drhinanurullah@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Luqman Unani Medical College Hospital & Research Centre  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  Tablet Asaroon   3 tablets of 500mg each, twice daily orally for 3 days in 2 consecutive menstrual cycles 
Comparator Agent  Tablet Mefenamic acid  1 tablet of 500mg twice daily orally for 3 days in 2 consecutive cycles. 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Married and unmarried patients between 15 to 35 years of ages having regular menstrual cycles
Patient diagnosed with primary dysmenorrhea
Patients with Visual Analog Scale less than or equal to 4cm for at least three menstrual cycles before this study 
 
ExclusionCriteria 
Details  Pelvic disease such as fibroid adenomyosis PID endometrial polyp ovarian tumour
Irregular menstrual cycles
Pregnancy and lactation
Systemic illness
Oral contraceptives and those Wearing IUCD devices
Participants with congenital anomalies of uterus 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in Severity of pain determined by VAS
Change in duration of menstrual pain 
before after treatment 
 
Secondary Outcome  
Outcome  TimePoints 
Change in HRQoL determined by SF-12 v1 health survey questionnaire
Change in PBLAC score for menstrual blood loss 
before after treatment 
 
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)   24/07/2023 
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="1" 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drhinanurullah@gmail.com].

  6. For how long will this data be available start date provided 01-01-2025 and end date provided 01-01-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Dysmenorrhea (Difficult menstrual flow) is one of the most prevalent gynaecological problems that affects about half of all female adolescents or college-bound females, It interferes with their daily activities. One of the most frequent menstruation symptoms worldwide among people of reproductive age is dysmenorrhea, which is underdiagnosed and undertreated. It carries a worse illness burden than any other gynaecological condition in underdeveloped nations.  Primary dysmenorrhea and secondary dysmenorrhea are the two main kinds of dysmenorrhea. Primary dysmenorrhea is described as menstrual cramping pain without any underlying pelvic pathology, and secondary dysmenorrhea is described as menstrual discomfort caused by any underlying pelvic disease. The most frequent justification for missing time at school, work, or family doctor appointments is dysmenorrhea ,and it occurs in ovulatory cycles, hence it makes its appearance a few years after menarche . It is still unclear how often primary dysmenorrhea actually is. However, Goerge and Bhaduri found dysmenorrhea to be a common problem in India with the prevalence of 87.7%.  According to the WHO Data, as many as 94% of young girls aged 10-20 and 8.8% of woman aged 19-41 suffer from menstrual pain Primary dysmenorrhea can be treated with a range of pharmaceutical and non-pharmacological techniques, such as non-steroidal anti-inflammatory medications (NSAIDs) and oral contraceptives.  The effectiveness of oral contraceptives and NSAIDs is considerable, however failure rates might still range from 20% to 25%. However analgesic are not an effective solution because of the risks for decreased effectiveness and increasing dependency . Some women with primary dysmenorrhea may not tolerate or be contraindicated for this therapy.  Although there are treatments for menstruation pain, getting full relief is still challenging. Therefore, a low-toxic alternative herbal treatment is necessary . Terms used for dysmenorrhea in the Unani literature are dard-i-rahim , waja’al-rahim, or auja al-rahim and usr-i-tamth and to treat this condition, several drugs have been mentioned for oral as well as local application like birinjasif, kharnub, bazrulbanj, zarawand, mur, irsa, habbulgaar, pudina, jawitri,tukhme karafs ,rewand khatae, amaltas  .Asaroon (Asarum europaeum L.), is one of them which can be given orally to relief dard al-rahim Numerous studies have shown that the extract of plants in the genus Asarum contains a rich complex of biologically active substances, including alkaloids, flavonoids, triterpene saponins, steroids, phlobatanin, amino acids, coumarins, higher fatty acids, polysaccharides, vitamins of group B, C, and E, essential oils, and others. Asarum (asaaroon) is currently scientifically and pharmacologically proven for its anti-inflammatory activity in animal models and are therefore can be helpful in   reduction of menstrual pain Considering this fact, it has been decided to conduct the clinical trial to evaluate the efficacy of Asaroon in patients with primary dysmenorrhoea in comparison with mefenamic acid.

 
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