| CTRI Number |
CTRI/2020/06/026180 [Registered on: 26/06/2020] Trial Registered Prospectively |
| Last Modified On: |
25/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Usefulness of homoeopathic medicine in PCOS |
|
Scientific Title of Study
|
Clinical Utility of Murphy Repertory in the selection of medicine for Polycystic Ovarian Syndrome |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neha Sharma |
| Designation |
Post Graduate Trainee |
| Affiliation |
National Homoeopathic Medical College and hospital |
| Address |
Department of Repertory Room no 10 National Homoeopathic Medical College and Hospital Viraj Khand 1 Gomti Nagar Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
9454854951 |
| Fax |
|
| Email |
drnsharma08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vishwajeet Gupta |
| Designation |
Professor community medicine |
| Affiliation |
National Homoeopathic Medical College and hospital |
| Address |
Department of Community Medicine Room no 30
National Homoeopathic Medical College and Hospital Viraj Khand 1 Gomti Nagar Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
7000161425 |
| Fax |
|
| Email |
drvishwajeetgupta@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Neha Sharma |
| Designation |
Post Graduate Trainee |
| Affiliation |
National Homoeopathic Medical College and hospital |
| Address |
Department of Repertory Room no 10 National Homoeopathic Medical College and Hospital Viraj Khand 1
Gomti Nagar lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
9454854951 |
| Fax |
|
| Email |
drnsharma08@gmail.com |
|
|
Source of Monetary or Material Support
|
| Neha Sharma
Shakti Nagar Colony Bijnor 246701 Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Neha Sharma |
| Address |
Shakti Nagar Colony Bijnor 246701 Uttar Pradesh |
| Type of Sponsor |
Other [Neha Sharma] |
|
|
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 |
| Neha Sharma |
National Homoeopathic Medical College and Hospital |
Department General Medicine OPD No 11
Lucknow
UTTAR PRADESH |
9454854951
drnsharma08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
It shall be prescribed in varying potency and repetition will be done as per need of the patient for a minimum of 3 months |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Unmarried and Married females with USG findings and Clinical evidence of Hirsutism
Patient willing to participate in study with written consent form and having BMI 23 and above |
|
| ExclusionCriteria |
| Details |
patients not willing to sign consent form or are undergoing treatment for any other disease
patient requiring emergency treatment |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to assess the utility of murphy repertory in selection of medicine for PCOS |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of homoeopathic medicine on hormonal levels and usg findings |
18 months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
29/06/2020 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
patient coming to opd will be assessed according to inclusion and exclusion criteria and will be enrolled for the study. complete case taking according to case proforma will be taken and will be repertorised using murphy repertory. best suited medicine will be prescribed to the patient and will be followed up for every 15 days for consecutive 6 months or as per need of the case. pre and post asessment will be done using different scales of PCOS and investigations findings. |