| CTRI Number |
CTRI/2024/05/067451 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
09/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic treatment in adenomyosis |
|
Scientific Title of Study
|
Role of individualized homoeopathic medicine in the treatment of adenomyosis: An open label prospective clinical 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 |
Arup Kumar Mondal |
| Designation |
Post Graduate Trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD No-18, Department of Homoeopathic Materia Medica, National Institute of Homoeopathy,Block-GE,Sector-3,Salt Lake, Kolkata-700106, West Bengal
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
9874616957 |
| Fax |
|
| Email |
loginarup@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Usha Ghelani Uchat |
| Designation |
Professor |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD No-18, Department of Homoeopathic Materia Medica, National Institute of Homoeopathy,Block-GE,Sector-3,Salt Lake, Kolkata-700106, West Bengal
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
9830966265 |
| Fax |
|
| Email |
ushauchat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arup Kumar Mondal |
| Designation |
Post Graduate Trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD No-18, Department of Homoeopathic Materia Medica, National Institute of Homoeopathy,Block-GE,Sector-3,Salt Lake, Kolkata-700106, West Bengal
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
9874616957 |
| Fax |
|
| Email |
loginarup@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy, Block-GE,Sector-3,Salt Lake,Kolkata-700106,West Bengal |
|
|
Primary Sponsor
|
| Name |
Arup Kumar Mondal |
| Address |
National Institute of Homoeopathy, Block-GE,Sector-3,Salt Lake,Kolkata-700106,West Bengal |
| 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 Arup Kumar Mondal |
National Institute of Homoeopathy |
OPD Number 18, Department of Homoeopathic Materia Medica, National Institute of Homoeopathy, GE Block, Sector III, Salt Lake, Kolkata 700106
North Twentyfour Parganas
WEST BENGAL |
9874616957
loginarup@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethical Committee of the National Institute Of Homoeopathy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N800||Endometriosis of uterus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine |
Homoeopathic Medicine will be
prescribed according to the
symptom similarity for a period of 6 months.
Medicine will be prescribed in both centesimal and 50 millesimal potency.
Doses and potency required for each case and repetition will be as per homoeopathic principle and individual requirement of the case.
Route of administration
will be orally.
Total duration of therapy will be 6 months for each patient. |
| Comparator Agent |
NIL |
As because this is a single arm
non-randomized study, comparator group is not required |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. Female patient with a positive diagnostic
finding for adenomyosis.
2. Women of age group 18-60 years.
3. Patients willing to give consent for
participating in the study.
4. Patients who can read Bengali and/or Hindi and/or 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
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numeric Rating Scale (NRS) Measurement for menstrual pain. The NRS is one of
the most commonly used scales having a range from 0-10, where ‘0’ denotes no pain
and ‘10’ denotes worst possible pain imaginable.
• Pictorial blood loss assessment chart (PBAC) measurement for menstrual
bleeding. The chart consists of a series of diagrams which depict staining, clots and
flooding. The number of sanitary pad/tampons used each day during menstruation is
recorded by placing a tally mark in the next box. For scoring row total is multiplied by multiplying factor for each row. |
At baseline and 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| n attempt will be made to show changes in the pathology through lab investigations – USG (lower abdomen and pelvis)/ TVS/MRI (lower abdomen and pelvis) |
At baseline and 6 month |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
25/05/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
i. A minimum of 30 samples will be taken in this study. ii. Inclusion & exclusion criteria will be strictly maintained. iii. Cases will be taken in standard case taking format. iv. Data from the patients will be taken in details according to the instructions given in Organon of Medicine. v. Data/score will be recorded at baseline and on NRS at baseline and after 3 months and 6 months. vi. Menstrual blood loss will be assessed on PBAC at baseline, 3rd month and 6th month. vii. Each case will be studied properly through evaluation of symptoms & construction of qualitative totality of symptoms. viii. Each case will be assessed periodically or as per the need of the case to follow up the medicinal action through clinical assessment, expert opinion as well as relevant laboratory investigations. ix. Statistical analysis will be done by comparing the data obtained at baseline and 6th
month. x. At the end
of the study the result will be analysed with proper statistical technique to show whether the
changes made by Individualized Homoeopathic medicine are significant or not. |