| CTRI Number |
CTRI/2025/11/097262 [Registered on: 11/11/2025] Trial Registered Prospectively |
| Last Modified On: |
11/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Finding out whether centesimal or 50 millesimal homoeopathic doses help better in women with PCOS |
|
Scientific Title of Study
|
A Comparative Study On The Effectiveness Of Centesimal And 50 Millesimal Potency Of Individualised Homoeopathic Medicines In The Management Of Polycystic Ovarian Syndrome In Women Of Reproductive Age Group |
| 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 Kavya S M |
| Designation |
Post Graduate Student |
| Affiliation |
Government Homoeopathic Medical College Iranimuttom Manacaud P.O Thiruvanathapuram 695009 |
| Address |
Department of Organon of Medicine Government Homoeopathic Medical College Iranimuttom Manacaud P.O 695009 Thiruvanathapuram Kerala India
Thiruvananthapuram
KERALA
695009
India |
| Phone |
8075361350 |
| Fax |
|
| Email |
kavya.rmk131296@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preema E P BHMS,MD HOM |
| Designation |
Professor and HOD |
| Affiliation |
Government Homoepathic Medical College Iranimuttom Manacaud P.O Thiruvanthapuram 695009 |
| Address |
Department of Organon of Medicine Government Homoepathic Medical College Iranimuttom Manacaud P.O 695009 Thiruvananthapuram Kerala India
Thiruvananthapuram
KERALA
695009
India |
| Phone |
8547714025 |
| Fax |
|
| Email |
preemariyas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kavya S M |
| Designation |
Post Graduate Scholar |
| Affiliation |
Govt.Homoeopathic Medical College,TVM |
| Address |
Department of Organon of Medicine
Government Homoeopathic Medical College Iranimuttom Manacaud P.O Thiruvanthapuram 695009
Thiruvananthapuram
KERALA
695009
India |
| Phone |
8075361350 |
| Fax |
|
| Email |
kavya.rmk131296@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Homoeopathic Medical College,Thiruvananthapuram
Kerala,Pin:695009 |
|
|
Primary Sponsor
|
| Name |
Dr Kavya S M |
| Address |
Postgraduate Scholar
Department of Organon of Medicine
Government Homoeopathic Medical College Iranimuttam Manacaud P O 695009 Thiruvananthapuram Kerala 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 Kavya S M |
Government Homoepathic Medical College Iranimuttom Manacaud P.O Thiruvanthapuram 695009 |
OP No 2 and OP No 3
Thiruvananthapuram
KERALA |
8075361350
kavya.rmk131296@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Govt.Homoeopathic Medical College,Thiruvananthapuram Iranimuttom Manacaud P O Thiruvananthapuram 695009 Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N911||Secondary amenorrhea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
50 millesimal Potency of Individualised Homoeopathic Medicines. |
Group B Patients are given individualised Homoeopathic medicines in 50 Millesimal scale of potentisation in suitable dose for the case of disease according to the principles of Homoeopathy and each case will be reviewed at 1 month interval and will be followed for a period of 3 months. |
| Intervention |
Centesimal Potency of Individualised Homoeopathic Medicines |
Group A Patients are given individualised Homoeopathic medicines in centesimal scale of potentisation in suitable dose for the case of disease according to the principles of Homoeopathy and each case will be reviewed at 1 month interval and will be followed for a period of 3 months. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Subjects belonging to women of reproductive age group between 15-45 years.
Subjects fulfilling diagnostic criteria of PCOS |
|
| ExclusionCriteria |
| Details |
1) Pregnant and lactating women.
2) Those who are taking oral contraceptives.
3) Subjects under conventional medicinal therapy.
4) Cases complicated with uterine fibroid , endometriosis and malignancies.
5) Cushing’s syndrome or acromegaly
6) Intellectually disabled subjects. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the effectiveness of individualised Homoeopathic medicines in centesimal
and 50 millesimal potency in managing PCOS in women of reproductive age group by
assessing the changes in Rotterdam’s Criteria. |
Each case will be reviewed at maximum period of 1 month interval or when situation
demands and will be followed for a period of 3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
25/11/2025 |
| 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)
|
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
|
The study is a prospective experimental double arm study designed to compare the effectiveness of two different Homoeopathic potency scales The centesimal scale and 50millesimal scale when using individualised Homoeopathic medicines for the management of PCOS in women of reproductive age group 15-45 years.Study setting is at the outpatient and inpatient departments of Govt Homoeopathic Medical College Thiruvananthapuram.A total of 48 cases are needed with 24 subjects in each study arm.Purposive consecutive Sampling is done.Diagnosis is based on the Rotterdam’s criteria and ultrasonography.The study duration is one year.Each case will be followed for a period of 3months after enrollment. |