| CTRI Number |
CTRI/2024/08/072952 [Registered on: 23/08/2024] Trial Registered Prospectively |
| Last Modified On: |
23/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic treatment in Resolution of Adenomyosis |
|
Scientific Title of Study
|
A Clinical Interventional Study To Find Out The Effectiveness Of Individualized Homoeopathic Medicine In Resolution Of Adenomyosis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Reshma Ramanan |
| Designation |
Post Graduate Scholar, Department of Practice Of Medicine |
| Affiliation |
National Homoeopathy Research Institute in Mental Health |
| Address |
Department of Practice of Medicine National Homoeopathy Research Institute In Mental Health , Sachivothamapuram (P.O), Kurichy
Kottayam
KERALA
686532
India |
| Phone |
8848049207 |
| Fax |
|
| Email |
rreshma68838@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinitha E R |
| Designation |
Associate Professor / Research Officer , Scientist II , Department Of Practice Of Medicine |
| Affiliation |
National Homoeopathy Research Institute In Mental Health |
| Address |
Department of Practice of Medicine ,National Homoeopathy Research Institute In Mental Health ,Sachivothamapuram (P.O) , Kurichy.
Kottayam
KERALA
686532
India |
| Phone |
9567847444 |
| Fax |
|
| Email |
vinitha_sajeev@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinitha ER |
| Designation |
Associate Professor/ Research Officer, Scientist II , Department Of Practice Of Medicine |
| Affiliation |
National Homoeopathy Research Institute In Mental Health |
| Address |
Department of Practice of Medicine ,National Homoeopathy Research Institute In Mental Health , Sachivothamapuram (P.O) , Kurichy.
Kottayam
KERALA
686532
India |
| Phone |
9567847444 |
| Fax |
|
| Email |
vinitha_sajeev@yahoo.in |
|
|
Source of Monetary or Material Support
|
| National Homoeopathy Research Institute In Mental Health, Sachivothamapuram p.o,Kurichy,Kottayam ,686532, Kerala ,India |
|
|
Primary Sponsor
|
| Name |
Dr. Reshma Ramanan |
| Address |
National Homoeopathy Research Institute In Mental Health , Sachivothamapuram p.o, Kurichy , Kottayam , Kerala , 686532, India |
| 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 Reshma Ramanan |
National Homoeopathy Research Institute in Mental Health |
OPD, IPD, Camps and peripheral units ,Department of Practice of medicine , National Homoeopathy Research Institute in Mental Health , Sachivothamapuram p.o , kurichy
Kottayam
KERALA |
8848049207
rreshma68838@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee - National Homoeopathy Research Institute in Mental Health kottayam |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N859||Noninflammatory disorder of uterus, unspecified, (2) ICD-10 Condition: N858||Other specified noninflammatory disorders of uterus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine |
The homoeopathic interventions will be done with centesimal potencies ranging from 6C to 50M . Individualized Homeopathic medicine will be given in minimum dose and repetition will be according to the severity of symptoms of patient. Frequency of route of administration will be orally once in a month and thus the total intervention period will be 12 months . |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1. Age group : 18 - 50 years
2. Patients with positive Ultrasonography findings for Adenomyosis. |
|
| ExclusionCriteria |
| Details |
1. Cases with active malignancy.
2. Patients with known serious systemic illness
3. Haemoglobin level less than 7g / dl .
4. Uterine fibroid with size greater than 7cm
5. Patients under regular conventional treatment for dysmenorrhea.
4 . Pregnant & Lactating women.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Outcome measurement can be done by ultrasonographic (Abdomen and Pelvis) findings at baseline and at 6 month and by the end of the study following administration of Individualized Homoeopathic medicine. |
At baseline , 6th month and 12th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in symptoms are assessed based on the WaLLID score & Menstrual Bleeding Questionnaire. |
At baseline, 3rd month, 6th month, 9th month & 12th month |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
04/09/2024 |
| 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
|
This study is an open label, single arm,clinical interventional study to determine the Effectiveness of Individualized Homoeopathic Medicine in Resolution of Adenomyosis , that will be conducted in OPD, IPD and Peripheral units of Department of Practice of Medicine at National Homoeopathy Research Institute in Mental Health , Kottayam . The primary outcome is measured by assessing the ultrasonographic (Abdomen and pelvis ) at baseline , 6th month and end of study . The secondary outcome is measured by assessing the severity of dysmenorrhea of adenomyosis using WaLLID score and reduction in heavy bleeding of adenomyosis using Heavy menstrual bleeding questionnaire at baseline, 3rd month, 6th month, 9th month , and at end of study. As the atudy with the aforementioned domains is one of its kind , it aims to make the efforts to other possibilities for future research in the effectiveness of Individualized Homoeopathic Medicine in Resolution of Adenomyosis . |