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CTRI Number  CTRI/2023/07/055239 [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   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effects of hingwadi tail matrabasti and mefenamic acid in patients with dysmenorrhea 
Scientific Title of Study   Evaluation of comparative efficacy of Hingwadi tail matrabasti versus Mefenamic acid in management of Kashtartava (primary spasmodic dysmenorrhea)  
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 Priya Chawle 
Designation  Associate professor 
Affiliation  Datta Meghe Ayurvedic college hospital and research centre, nagpur 
Address  Department of Prasutitantra and Strioga, Datta meghe ayurvedic medical college hospital and research centre, wanadongari, Nagpur
Department of Prasutitantra and Strioga, Datta meghe ayurvedic medical college hospital and research centre, wanadongari, Nagpur
Nagpur
MAHARASHTRA
441110
India 
Phone  7499577917  
Fax    
Email  priyachawle1411@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Reena Jaiswal 
Designation  Associate professor 
Affiliation  Mahatma Gandhi Ayurved College Hospital and Research Centre, Salod, Wardha 
Address  Department of Shalyatantra, Mahatma Gandhi Ayurved College Hospital and Research Centre, Salod, Wardha, Dist.- Wardha
Department of Shalyatantra, Mahatma Gandhi Ayurved College Hospital and Research Centre, Salod, Wardha, Dist.- Wardha
Wardha
MAHARASHTRA
442001
India 
Phone  8080403738   
Fax    
Email  devyanidasar06@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Priya chawle 
Designation  Associate professor 
Affiliation  Mahatma Gandhi Ayurved College Hospital and Research Centre, Salod, Wardha 
Address  Department of prasutitantra & striroga, Datta Meghe Ayurvedic Medical College Hospital and Research Centre, Wanadongari, nagpur Dist.- nagpur
Department of prasutitantra & striroga, Datta Meghe Ayurvedic Medical College Hospital and Research Centre, Wanadongari, nagpur Dist.- nagpur
Nagpur
MAHARASHTRA
442001
India 
Phone  7499577917  
Fax    
Email  priyachawle1411@gmail.com  
 
Source of Monetary or Material Support  
Datta Meghe Institute of Medical Science 
 
Primary Sponsor  
Name  Datta Meghe Institute of Medical Science 
Address  Atrey layout, Pratap Nagar, Nagpur 
Type of Sponsor  Research institution and hospital 
 
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 Priya Chawle  Datta Meghe Institute of Medical Science  Prasutitantra & striroga dept. G003, Hospital building, Mahatma Gandhi Ayurved Medical College Hospital & Research Centre. Wardha, MAHARASHTRA
Wardha
MAHARASHTRA 
7499577917

priyachawle1411@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Doctoral Research 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. Ayurveda Condition: UDAVARTINI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: matrabasti, Procedure details: matrabasti (per rectal administration of medicated oil.)
(1) Medicine Name: hingwadi tail, Reference: bhaishajya ratnavali, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 7 Days
2Comparator Arm (Non Ayurveda)-Mefenamic Acid250 mg twice a day orally for 3 months
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Female 
Details  1. Patients diagnosed as primary spasmodic dysmenorrhoea.
2. Patients complaining painful menstruation for first two days for two Consecutive cycles.
3. Patients having regular menstrual cycles.
 
 
ExclusionCriteria 
Details  1. Patients with major systemic diseases.
2. Patients having congenital anomalies leading to dysmenorrhea.
3. Patients having any detectable organic pelvic pathology.
4. Patients on hormonal therapy
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary outcome measure: change in subjective
parameter like abdominal Pain during menstruation, waist-hip pain, Low backache, Duration of Pain, Nausea, Vomiting, fatigue, diarrhea, headache. 
assess after 3 consecutive menstrual cycles 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcome measure: change in
objective parameter VAS 
assess after 3 consecutive menstrual cycles 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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 3 
Date of First Enrollment (India)   01/09/2023 
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="25" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

           Dysmenorrhea defines as painful menstruation of sufficient magnitude so as to incapacitate day-to-day activities. Dysmenorrhea can be of two types, primary dysmenorrhea, secondary dysmenorrhea. Primary dysmenorrhea is defined as painful menstruation without any obvious pelvic pathology. Secondary dysmenorrhea is defined as painful menstruation associated with underlying pelvic pathology. It is seen in 50 % of post-pubertal women during 18-25 years of age. However, 20% of women have severe primary dysmenorrhea needing treatment. 

            In classical Ayurveda, dysmenorrhea is referred to as Kashtartava. Kashtartava is a broad term that refers to any and all troubles and illnesses that a woman may experience during or before menstruation. in classical Ayurveda text bhaishajya ratnavali, Hingwadi tail is described for the treatment of kashtartava. the classical drug will be compared with the efficacy of the standard drug mefenamic acid. Diagnosis will be done on the basis of the symptoms of kashtartava (primary spasmodic dysmenorrhea). Assessment will be done on the basis of improvement of the clinical features. Measurement of severity on VAS (visual analog scale). The VAS using a 10-cm line represented the continuum of the participant’s opinion of the degree of painTotal 2 follow up will be taken. It will be after the 3 menstrual cycles.                                         

 
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