| CTRI Number |
CTRI/2024/04/066308 [Registered on: 25/04/2024] Trial Registered Prospectively |
| Last Modified On: |
25/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Pain management in endometriosis by Homoeopathic medicine |
|
Scientific Title of Study
|
To study the utility of individualized homoeopathic medicine in the pain management of women suffering from Endometriosis |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tripti Gupta |
| Designation |
Assistant professor Gynae /obs |
| Affiliation |
National Homoeopathic Medical College |
| Address |
Room no 11 National Homoeopathic Medical College and Hospital 1 Vraj Khand Gomti Nagar lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
9450651429 |
| Fax |
|
| Email |
dr.triptigupta2013@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Tripti Gupta |
| Designation |
Assistant professor Obs/GYnae |
| Affiliation |
National Homoeopathic Medical College |
| Address |
Room no 11National Homoeopathic Medical College and Hospital 1 Vraj Khand Gomti Nagar lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
9450651429 |
| Fax |
|
| Email |
dr.triptigupta2013@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neeraj Gandhi |
| Designation |
Assistant Professor surgery |
| Affiliation |
National Homoeopathic Medical College |
| Address |
Room No 11 National Homoeopathic Medical College and Hospital 1 Vraj Khand Gomti Nagar lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
6307229554 |
| Fax |
|
| Email |
dr.neerajgandhi2012@gmail.com |
|
|
Source of Monetary or Material Support
|
| National homoeopathic medical college1 Viraj Khand Gomti Nagar Lucknow Uttar pradesh India 226010 |
|
|
Primary Sponsor
|
| Name |
Principal |
| Address |
National Homoeopathic Medical College and Hospital 1 Vraj Khand Gomti Nagar Lucknow Uttar Pradesh India 226010 |
| Type of Sponsor |
Government medical college |
|
|
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 Tripti Gupta |
National Homoeopathic Medical College 1 virat khand Gomti nagar Lucnow Uttar Pradesh 226016 |
OPD Room No 11 Dept of Gynae/Obs
Lucknow
UTTAR PRADESH |
09450651429
dr.triptigupta2013@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethic Committee National Homoeopathic Medical College and Hospital 1 Viraj Khand Gomti Nagar Lucknow Uttar Pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N809||Endometriosis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic medicine after selection of medicine following homoeopathic principals. |
according to each case in varying potency as per need and repetitions shall be according to need of each case |
| Comparator Agent |
none as its single arm study |
not required |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1 Women of age between 15-45 yrs.
2 Women having symptoms suggesting of endometriosis.
3 Women having USG uterine adnexa shows endometriosis.
4 Women coming to OPD with known case of endometriosis or referred from any other center.
5 Women who are willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1 Women not willing to give their consent for the study.
2 Women having uncontrollable diabetes mellitus, hypertension.
3 Women having life threatening diseases like cancer.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Measure change in severity of pelvic pain as determined by modifications of the VAS score (range 0 to 10) for five modalities of EAPP (dysmenorrhea, deep dyspareunia, non-cyclic pelvic pain, cyclic bowel pain and/or cyclic urinary pain).
1 To monitor Ultrasonographical changes
2 (USG Uterine adnexa) at the end of 6 months of treatment.
|
At the start of study and every 2 weeks after the start
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Measures changes in the scores for quality of life, assessed with SF-36 Health Survey Questionnaire |
at start of study then every 2 weeks |
|
|
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)
|
06/05/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
title to study the utility of individualized homoeopathic medicine in pain management in women suffering from Endometriosis. . in the study utility shall be measured using VAS score and SF 36 heath survey. study will start with consent after which detailed homoeopathic case taking will be done on willing patient and medicine shall be given. patient shall be followed up fortnightly. study shall continue for 2 years but min of 6 months follow up shall be required for individual case. Study shall be conducted at NHMC Lucknow |