| CTRI Number |
CTRI/2022/01/039166 [Registered on: 05/01/2022] Trial Registered Prospectively |
| Last Modified On: |
15/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
EFFECT OF REVULSIVE COMPRESS ON PRIMARY DYSMENORRHOEA |
|
Scientific Title of Study
|
EFFICACY OF REVULSIVE COMPRESS IN PRIMARY DYSMENORRHOEA –
A RANDOMIZED CONTROLLED TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr JOSINA JOHN |
| Designation |
Post graduate |
| Affiliation |
SDM college of naturopathy and yogic sciences |
| Address |
Dept. of Naturopathy, SDM college of naturopathy and yogic sciences
Ujire
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
8277121712 |
| Fax |
|
| Email |
josnajoe77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shashikiran HC |
| Designation |
Asst. Professor , Department of yoga |
| Affiliation |
SDM college of naturopathy and yogic sciences |
| Address |
SDM college of naturopathy and yogic sciences
Ujire
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9483004440 |
| Fax |
|
| Email |
shashiputtubnys@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr JOSINA JOHN |
| Designation |
Post graduate |
| Affiliation |
SDM college of naturopathy and yogic sciences |
| Address |
SDM college of naturopathy and yogic sciences
Ujire
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
8277121712 |
| Fax |
|
| Email |
josnajoe77@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM college of naturopathy and yogic sciences |
|
|
Primary Sponsor
|
| Name |
Dr Josina John |
| Address |
Dept. of naturopathy, SDM college of naturopathy and yogic sciences |
| 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 Josina John |
SDM college of naturopathy and yogic sciences |
SDM, college of naturopathy and yogic sciences and ladies hostel
Dakshina Kannada
KARNATAKA |
9483004440
josnajoe77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| sri dharmasthala manjunatheshwara college of naturopathy and yogic sciences , ujire |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
PRIMARY DYSMENORRHEA |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
no intervention |
with or without pharmocological management |
| Intervention |
revulsive compress |
revulsive compress over abdomen for 20 minutes for 3 months. |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
23.00 Year(s) |
| Gender |
Female |
| Details |
1. women with primary dysmenorrhoea.
2. women with regular menstrual cycles
3. dysmenorrhoea in majority of the cycles
4. suffering from dysmenorrhoea since 1 year
5. who are willing to participate |
|
| ExclusionCriteria |
| Details |
1. systemic illness
2. pelvic pathology |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.pain analogue scale
2. menstrual cramps
3.assessment of systemic symptoms
|
baseline
post intervention
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| systemic symptoms |
baseline
post intervention |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 1 |
|
Date of First Enrollment (India)
|
15/01/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/01/2022 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="20" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Dysmenorrhea is a gynecological medical condition characterized by severe uterine pain during menstruation. The increasing incidence in primary dysmenorrhea has been attributed to stress and lifestyle. Present method of management include pharmacological approaches which are known have side effects resulting in an increased use of CAM therapies. Naturopathy, a nonpharmacological intervention is being used extensively for pain relief in primary dysmenorrhoea. Revulsive compress is a hydrotherapy based treatment of choice in the management of primary dysmenorrhoea. Though commonly used by naturopathy physicians, there is a need to create scientific evidence for its therapeutic use. Hence, the present study aimed at assessing the efficacy of a revulsive compress in the management of primary dysmenorrhoea on the severity of pain, systemic symptoms and intensity of muscle cramps associated with menstruation adolescent girls. |