| CTRI Number |
CTRI/2023/04/051391 [Registered on: 06/04/2023] Trial Registered Prospectively |
| Last Modified On: |
06/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
How does the Bio-Psycho-Social Model help in Holistic Homoeopathic Management of Poly Cystic Ovarian Syndrome (PCOS). This experiment will be tested by patients as well, by answering questions of WHOQOL BREF scale. |
|
Scientific Title of Study
|
Application of Bio-Psycho-Social Model in Holistic Homoeopathic Management and its impact as assessed by WHOQOL BREF scale in Poly Cystic Ovarian Syndrome (PCOS): An Experimental Uncontrolled Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gayatri Patel |
| Designation |
Visiting Professor, Dept of Psychiatry |
| Affiliation |
Dr M L Dhawale Memorial Homoeopathic Institute |
| Address |
Dr M L Dhawale Memorial Homoeopathic Institute
Boisar Road
Opposite S T stand
Palghar 401404
Dr M L Dhawale Memorial Homoeopathic Institute
Boisar Road
Opposite S T stand
Palghar 401404
Thane
MAHARASHTRA
401404
India |
| Phone |
9869236654 |
| Fax |
|
| Email |
gayatripatel2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chirag Shah |
| Designation |
Professor and HOD Dept of Physiology and Biochemistry |
| Affiliation |
Smt Malini Kishore Sanghvi Homoeopathic Medical College and Hospital |
| Address |
Smt Malini Kishore Sanghvi Homoeopathic Medical College and Hospital
Karjan
Vadodara
Vadodara
GUJARAT
391240
India |
| Phone |
9376939627 |
| Fax |
|
| Email |
chirashana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayatri Patel |
| Designation |
Visiting Professor, Dept of Psychiatry |
| Affiliation |
Dr M L Dhawale Memorial Homoeopathic Institute |
| Address |
Dr M L Dhawale Memorial Homoeopathic Institute
Boisar Road
Opposite S T stand
Palghar 401404
Dr M L Dhawale Memorial Homoeopathic Institute
Boisar Road
Opposite S T stand
Palghar 401404
Thane
MAHARASHTRA
401404
India |
| Phone |
9869236654 |
| Fax |
|
| Email |
gayatripatel2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr M L Dhawale Memorial Homoeopathic Hospital |
|
|
Primary Sponsor
|
| Name |
Dr M L Dhawale Memorial Homoeopathic Institute |
| Address |
M L Dhawale Memorial Homoeopathic Institute
Boisar Road
Opp S T stand
Palghar 401404
|
| Type of Sponsor |
Private 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 Gayatri Patel |
Dr M L Dhawale Memorial Homoeopathic Institute |
Boisar Road
Opposite S T stand
Palghar 401404
Thane
MAHARASHTRA |
9869236654
gayatripatel2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Smt Malini Kishore Sanghvi Homoeopathic Medical College and Hospital Karjan Homoeopathic Medical |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E282||Polycystic ovarian syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic medicine |
Indicated Homoeopathic chronic, acute and or intercurrent medicine in centesimal and millesimal scale with placebo to stabilize the patient |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
11.00 Year(s) |
| Age To |
53.00 Year(s) |
| Gender |
Female |
| Details |
Diagnosed cases of PCOS as per Rotterdam’s criteria
Cases from menarche to Menopause Cases with other co- morbidities related to PCOS/other endocrinal disorders will be included with prior testing e.g. TSH, Hyperprolactinemia.
Patients under hormonal treatment and Metformin will be taken by stopping this treatment
|
|
| ExclusionCriteria |
| Details |
Cases of PCOS with primary infertility as Chief complaint will be excluded
Cases with advanced psychiatric illness will not be taken for study
. Patients with on going treatment for advance autoimmune disorders will be excluded
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Applying the BPS model will assist in understanding the different stressors or causes) individually and their interplay which produce disease expressions.
This global view will greatly contribute to formulate in depth holistic Homoeopathic management by evaluating the importance of different factors, namely, Bio, Psycho and Social vertically and cross-sectionally.
The BPS model will assist in improving the QOL of patients with PCOS through identification of prominent factors (predisposing, maintaining and precipitating at Bio- Psycho - Social level) and applying appropriate holistic Homoeopathic management
|
2 years 6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The study will contribute to expanding the living Materia Medica images as the cause effect phenomena will get highlighted in the study |
2 years 6 months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
24/04/2023 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Recruitment of samples will begin by approximately mid-February after the CTRI approval. The sampling will start at the MLDMHI centers. |