| CTRI Number |
CTRI/2021/04/032599 [Registered on: 07/04/2021] Trial Registered Prospectively |
| Last Modified On: |
19/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
ROLE OF INDIVIDUALIZED HOMOEOPATHIC MEDICINE IN TREATING THE SYMPTOMS OF ENDOMETRIOSIS |
|
Scientific Title of Study
|
ASSESSING THE ROLE OF INDIVIDUALIZED HOMOEOPATHIC MEDICINE IN TREATING THE SYMPTOMS OF ENDOMETRIOSIS USING MINTON’S UTERINE THERAPEUTICS – AN OPEN LABEL CLINICAL TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arpita Sen |
| Designation |
Post graduate trainee |
| Affiliation |
National Institute of Homoeopathy, Department of Organon of Medicine, OPD no. 4 |
| Address |
Block GE, Sector 3, Salt lake, Kolkata, West Bengal,700106
,Block GE, Sector 3, Salt lake, Kolkata, West Bengal,700106
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
8837357872 |
| Fax |
|
| Email |
drarpitasen666@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ompriya Mishra |
| Designation |
HOD and Lecturer Department of Gynecology and Obstetrics |
| Affiliation |
National Institute of Homoeopathy, Department of Gynaecology and Obstetrics, OPD no. 4 |
| Address |
Block GE, Sector 3, Salt lake, Kolkata, West Bengal,700106
.Block GE, Sector 3, Salt lake, Kolkata, West Bengal,700106
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
9432496545 |
| Fax |
|
| Email |
drompriyanih@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ompriya Mishra |
| Designation |
HOD and Lecturer Department of Gynecology and Obstetrics |
| Affiliation |
National Institute of Homoeopathy, Department of Gynaecology and Obstetrics, OPD no.4 |
| Address |
Block GE, Sector 3, Salt lake, Kolkata, West Bengal,700106
, Block GE, Sector 3, Salt lake, Kolkata, West Bengal,700106
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
9432496545 |
| Fax |
|
| Email |
drompriyanih@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy |
|
|
Primary Sponsor
|
| Name |
National Institue of Homoeopathy |
| Address |
GE Block, Sector III, Bidhannagar, Kolkata, West Bengal 700106 |
| 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 |
| Arpita Sen |
National Institute of Homoeopathy |
Department of Organon of Medicine, National Institute of Homoeopathy, Block GE, Sector 3, Salt lake, Kolkata, West Bengal,700106
North Twentyfour Parganas
WEST BENGAL |
8837357872
drarpitasen666@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
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N80||Endometriosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine |
Individualized homoeopathic medicine will be selected through proper case taking and evaluation of symptoms with the help of Mintons Uterine Therapeutics. Dose will depend upon the status of the patient. Frequency will be depended upon the condition of patient. Route of administration will be through oral route. Duration of treatment will be six months |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Female patient with a positive diagnostic finding for Endometriosis.
2.Reproductive age group (18-45 years)
3.Patients willing to give consent for participating in the study.
4.Patients who can read Bengali and/ Hindi and/English.
|
|
| ExclusionCriteria |
| Details |
1.Pregnant women or lactating mothers.
2.Diagnosed cases of unstable psychiatric illness or other systemic disease affecting quality of life or some life threatening illness.
3.Patients not willing to participate in the study.
4.Substance abuse and/or dependence.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Numeric Rating Scale
2. RAND Item 36 Health Survey 1.0 Questionnaire |
Baseline and six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| An attempt will be made to show changes in the pathology through lab investigations- USG/TVS and/laparoscopy |
baseline to six months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2 |
|
Date of First Enrollment (India)
|
08/04/2021 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Endometriosis is a condition where tissue similar to the lining of the uterus (the endometrial stroma and glands, which should only be located inside the uterus) is found elsewhere in the body. Endometriosis is an estrogen dependent disease thus usually effects women of reproductive age group, having 20-50% prevalence in infertile women but it can be as high as 71-87% in women with chronic pelvic pain. Homoeopathic literature has given generous attention to female heath issues & endometriosis though not directly mentioned in the texts, is being incorporated through the description of various manifesting symptoms relating to the menstrual state and thus individualized homoeopathic medicines plays a considerable role in treating endometriosis. Minton’s Uterine Therapeutics is a Regional Clinical Repertory which serves as a useful monograph on the problems of menstruation & other related functions. An open non-randomized single arm prospective clinical study is being taken up at the OPD of National Institute of Homoeopathy, Kolkata. West Bengal. 40 patients presenting with symptoms of Endometriosis with a positive finding in either USG/TVS and/Laparoscopy will be taken for the study. Outcome data will be assessed primarily through symptoms using Numeric Rating Scale (recorded at baseline and then every 4 weeks for 6 months) & RAND Item 36 Health Survey 1.0 (recorded at baseline and at 6 months). Changes in the outcome will be tested at baseline and at 6 months by statistical tests as appropriate. An attempt will be made to show changes in the pathology through lab investigations - USG/TVS and/Laparoscopy as a secondary outcome measure. |