| CTRI Number |
CTRI/2024/12/077775 [Registered on: 06/12/2024] Trial Registered Prospectively |
| Last Modified On: |
04/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy of Matri in women with Primary Dysmenorrhoea |
|
Scientific Title of Study
|
Efficacy of Indian make Transcutaneous Electric Nerve Stimulation Device
Matri in women with Primary Dysmenorrhoea- A Randomized 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 Ritu Sharma |
| Designation |
Professor and Head of Department of Obstetrics and Gynaecology |
| Affiliation |
Government Institute of Medical Sciences (GIMS) |
| Address |
Room no. 4152, 4rth floor, Department of Obstetrics and Gynaecology Government Institute of Medical Sciences (GIMS)
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9717001590 |
| Fax |
|
| Email |
drritu661@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ritu Sharma |
| Designation |
Professor and Head of Department of Obstetrics and Gynaecology |
| Affiliation |
Government Institute of Medical Sciences (GIMS) |
| Address |
Room no. 4152, 4rth floor, Department of Obstetrics and Gynaecology Government Institute of Medical Sciences (GIMS)
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9717001590 |
| Fax |
|
| Email |
drritu661@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Mukesh Kumar |
| Designation |
In-charge Clinical Trial Unit |
| Affiliation |
Government Institute of Medical Sciences (GIMS) |
| Address |
Room no. 4140, 4rth floor Government Institute of Medical Sciences (GIMS)
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
2010310
India |
| Phone |
9116161133 |
| Fax |
|
| Email |
ctu.gims@gmail.com |
|
|
Source of Monetary or Material Support
|
| Silifarm Technologies Pvt Ltd - Office Address -
Second Floor of Premises 20/1/5, Bhagaban Chatterjee Lane , Police station - Bantra , Howrah - 711101 , West Bengal , India |
|
|
Primary Sponsor
|
| Name |
Biotechnology ignition grant BIG |
| Address |
BIREC through Venture Centre
Entrepreneurship Development Center , NCL Innovation Park , Dr Homi Bhabha Road , Pashan , Pune - 411008 , Maharashtra , India |
| Type of Sponsor |
Government funding agency |
|
|
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 Ritu Sharma |
Government Institute of Medical Sciences (GIMS) |
Room no. 4152, 4rth floor, Department of Obstetrics and Gynaecology Government Institute of Medical Sciences (GIMS)
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH |
9717001590
drritu661@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics Committee Government Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N946||Dysmenorrhea, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo Device |
Will be given for 2 months |
| Intervention |
TENS Device Matri |
Will be given for 2 months |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
1. Women suffering from primary dysmenorrhoea with regular cycles
2. Working ability, Location, Intensity, Days of dysmenorrhea score (WaLIDD score) more than or equal 5
3. Age 14 - 30 Years |
|
| ExclusionCriteria |
| Details |
1. Women taking Oral Contraceptive Pills OCPs
2. Patients with dysmenorrhea secondary to the pathologies like endometriosis,
uterine myoma, uterine malformations, other similar uterine diseases, pelvic
inflammatory disease, congenital Mullerian anomalies, ovarian cysts, or
inflammatory bowel disease. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the effectiveness of the new Indian make TENS device (Matri)
for managing Primary Dysmenorrhoea using subjective Visual Analog Scale
pain score (VAS score) |
1. To evaluate the effectiveness of the new Indian make TENS device (Matri)
for managing Primary Dysmenorrhoea using subjective Visual Analog Scale
pain score (VAS score) at base line , 1 month and 2nd month from base line |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the perceived adverse reactions of the new Indian make
Transcutaneous Electric Nerve Stimulation TENS Device (Matri)
2. To compare the quality of life before & after intervention
3. To assess patient acceptance for new Indian make Transcutaneous Electric
Nerve Stimulation TENS Device (Matri) for Primary Dysmenorrhoea |
1. Quality of life will be assessed using WHO short survey questionnaire SF-
12 at baseline, at the end of second cycle & again at the end of fourth cycle.
2. Patient’s acceptance for new Indian make Transcutaneous Electric Nerve
Stimulation TENS Device (MATRI) for Primary Dysmenorrhoea |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
16/12/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Primary dysmenorrhea is a common gynaecological problem consisting of painful cramps accompanying menstruation, without any evident pathology to account to it. The uterus is induced to contract frequently and disrhythmically, with increased basal tone and increased active pressure. The disease occurs in up to 50% of menstruating females and causes significant disruption in quality of life in 20%, resulting in non- attendance at work or school (1-4). The available treatment for this are nonsteroidal anti-inflammatory drugs and oral contraceptive pills OCPs which are often associated with adverse events (AEs). So many patients avoid taking them, and seek for other non-pharmaceutical alternatives. Transcutaneous electrical nerve stimulation (TENS), working on Gate control theory, is an established method for pain relief in various chronic conditions such as arthritis, back pain etc. This method offers a potential non-pharmaceutical alternative therapy for dysmenorrhea. It has been used in few research projects but is still not widely used for this indication (5-8). |