| CTRI Number |
CTRI/2018/05/013960 [Registered on: 18/05/2018] Trial Registered Prospectively |
| Last Modified On: |
02/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A cohort study to find out the efficacy of ayurveda treatment in the management of pelvic pain in pelvic endometriosis. |
|
Scientific Title of Study
|
A cohort study to find out the efficacy of specific ayurveda protocol in the management of pelvic pain in pelvic endometriosis(Vatiki yonivyapath) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anjuraj |
| Designation |
PG scholar |
| Affiliation |
Amrita School Of Ayurveda |
| Address |
DR.Anjuraj
PG scholar
Dept of Prasuti Tantra and Striroga
Amrita school of Ayurveda
Vallikavu
DR.Anjuraj
Vikas Bhavan
Kadakkal P O
Kollam
KERALA
690525
India |
| Phone |
8606643399 |
| Fax |
|
| Email |
anjulijo90@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrHemavathi S K |
| Designation |
Proffesor and HOD of dept of Prasuti tantra and Striroga |
| Affiliation |
Amrita university |
| Address |
DR.Hemavathi S K
Professor and HOD
Dept of Prasuti Tantra and Striroga
Amrita school of Ayurveda
Vallikavu
Kollam
KERALA
690525
India |
| Phone |
|
| Fax |
|
| Email |
drhemavathi.sk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anjuraj |
| Designation |
PG scholar |
| Affiliation |
Amrita university |
| Address |
DR.Anjuraj
Dept of Prasuti Tantra And Striroga
Amrita school of Ayurveda
Vallikavu
Kollam
KERALA
690525
India |
| Phone |
8606643399 |
| Fax |
|
| Email |
anjulijo90@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita School Of Ayurveda |
|
|
Primary Sponsor
|
| Name |
Amrita School Of Ayurveda |
| Address |
Amrita School Of Ayurveda
Vallikavu
Kollam
Kerala |
| 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 Anjuraj |
Amrita School of Ayurveda |
Department of Prasuti Tantra And Striroga
Kollam
KERALA |
8606643399
anjulijo90@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amrita Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N711||Chronic inflammatory disease of uterus, Pelvic endometriosis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Every married and unmarried women with pelvic pain due to endometriosis coming to OPD |
|
| ExclusionCriteria |
| Details |
1.Subjects who are pregnant
2.Patient with malignancy
3.Patient with chronic systemic illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in pelvic pain is assessed with VAS
Improvement in Quality Of Life is assessed with EHP-30 questionnaire |
Assessment of pain and QOL before and after treatment and observation for 3 consecutive menstrual cycles |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| QOL is assessed with EHP-30 questionnaire |
Before and after the treament |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2018 |
| 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="4"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Endometriosis is one of the important and mysterious gynaecological disorders which is defined as the presence of functioning endometrium in sites other than uterine mucosa.It is having an adverse effect in the physical and psychological health of the lady thus affecting the quality of her life.Endometriosis is found in 45% to 82% of women with chronic pelvic pain.The overall prevalence including both symptomatic and asymptomatic women is estimated to be 5% to 10%.Contemporary treatment for endometriosis like drug therapy,surgical corrections is often unsatisfactory as these cause various side effects and lead to early menopause and also chances of recurrence is common.In Prasuti tantra Striroga OPD of Amrita Ayurveda Hospital,a specific ayurveda protocol is being practised for endometriosis especially for pelvic pain.Proper documentation of the efficacy of this treatment is needed.So this study aims to observe and document the efficacy of specific ayurveda treatment protocol in the management of pain in endometriosis,which can also induce the regression of endometriosis and its symptoms without affecting the normal physiology of the lady. |