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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:N944||Primary dysmenorrhea. Ayurveda Condition: UDAVARTINI, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Procedure | - | mAtrAbastiH, मातà¥à¤°à¤¾à¤¬à¤¸à¥à¤¤à¤¿à¤ƒ | (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 | 2 | Comparator Arm (Non Ayurveda) | | - | Mefenamic Acid | 250 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 pain. Total 2 follow up will be taken. It will be after the 3 menstrual cycles. |