| CTRI Number |
CTRI/2018/02/011996 [Registered on: 20/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
09/04/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see the efficacy of trial medicine in Painful menstruation |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY TO ASSESS THE EFFECT OF YONISHOOLAHARA KASHAYA and ITS GHANA IN THE MANAGEMENT OF UDAVARTINI YONIVYAPATH wrt TO PRIMARY DYSMENORRHOEA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CMCPM5205P |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Madhu M |
| Designation |
Assistant Professor |
| Affiliation |
Parul Institute of Ayurveda |
| Address |
Parul Univerity
Limda
WAghodia tq
Vadodara
Gujarat
SCSVMV university
Kanchipuram
Vadodara
GUJARAT
391760
India |
| Phone |
8970167939 |
| Fax |
|
| Email |
drmadhu.ayu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhu M |
| Designation |
Assistant Professor |
| Affiliation |
Parul Institute of Ayurveda |
| Address |
Parul Univerity
Limda
WAghodia tq
Vadodara
Gujarat
SCSVMV University
Kanchipuram
Vadodara
GUJARAT
391760
India |
| Phone |
8970167939 |
| Fax |
|
| Email |
drmadhu.ayu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhu M |
| Designation |
Assistant Professor |
| Affiliation |
Parul Institute of Ayurveda |
| Address |
Parul Univerity
Limda
WAghodia tq
Vadodara
Gujarat
SCSVMV University
Kanchipuram
Vadodara
GUJARAT
391760
India |
| Phone |
8970167939 |
| Fax |
|
| Email |
drmadhu.ayu@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Madhu M |
| Address |
PhD scholar
SCSVMV University
Kanchipuram
Tamilnadu |
| Type of Sponsor |
Other [SELF] |
|
|
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 Madhu M |
Parul Ayurveda Hospital |
OPD no 111
Department of Prasuti Tantra and Stree Roga
Vadodara
GUJARAT |
8970167939
drmadhu.ayu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N944||Primary dysmenorrhea, Primary Dysmenorrhoea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Trial Group 1 |
Yonishoolahara kashaya is given 50ml BD 10days before menstruation in Udavartini Yoni vyapat (Primary dysmenorrhea) for 3 cycles |
| Comparator Agent |
Trial group 2 |
Yonishoolahara Ghana vati 500mg BD for 10days before menstruation for consecutive 3 menstrual cycles |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
Age between 16-25 years.
Painful menstruation for at least 2 consecutive cycles
Patients with regular menstrual cycles
|
|
| ExclusionCriteria |
| Details |
Cases of Secondary dysmenorrhoea with pelvic pathology- Fibroid of Uterus,Ovarian Cyst, Endometriosis, Menorrhagia, Malignancy.
Patient having any systemic diseases likely to influence the menstrual cycle.
Patient with IUCD
Patient’s on hormonal therapy
Patient having congenital anomalies leading to dysmenorrhoea
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of menstrual pain in dysmenorrhoea |
3months after each menstrual cycle |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Healthy individuals |
3 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/12/2017 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
1. Article-‘Severe pain is not normal, not ever during menstruation’! A critical & scientific analysis of causes of Dysmenorrhoea, in AAMJ ISSN: 2395-4159
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The PhD study of to find the efficacy of Yonishoolahara kashaya in Udavartini Yoni vyapat in special ref to Primary dysmenorrhea and to compare it with the same kashaya in vati form. Total 100 dysmenorrhea patients will recruited for the study.. the findings will be noted down in specially prepared case performa.. It is statistically analysed after completion of patient recruitment. |