| CTRI Number |
CTRI/2024/09/073326 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
28/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
POLYCYSTIC OVARIAN SYNDROME |
|
Scientific Title of Study
|
Effectiveness of the Homoeopathic Medicine Senecio Aureus in the Treatment of Polycystic Ovarian Syndrome |
| 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 Sajitha RB |
| Designation |
PG Scholar |
| Affiliation |
White memorial homoeo medical college and hospital |
| Address |
White memorial homoeo medical college and hospital Attoor Veeyanoor
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
8300833562 |
| Fax |
|
| Email |
sajithasreekutty507@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Binaya B V |
| Designation |
Associate Professor |
| Affiliation |
White memorial homoeo medical college and hospital |
| Address |
Department of Materia Medica
White memorial homoeo medical college and hospital Attoor Veeyanoor
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
9497267843 |
| Fax |
|
| Email |
binayabenjamin@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sajitha R B |
| Designation |
PG Scholar |
| Affiliation |
White memorial homoeo medical college and hospital |
| Address |
White memorial homoeo medical college Attoor Veeyanoor
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
8300833562 |
| Fax |
|
| Email |
sajithasreekutty507@gmail.com |
|
|
Source of Monetary or Material Support
|
| White memorial homoeo medical college and hospital Attoor Veeyanoor |
|
|
Primary Sponsor
|
| Name |
White memorial homoeo medical college and hospital |
| Address |
White memorial homoeo medical college and hospital Attoor Veeyanoor |
| 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 Sajitha R B |
White memorial homoeo medical college and hospital |
Department Materia Medica
White memorial homoeo medical college and hospital IPD OPD Peripheral Center
Kanniyakumari
TAMIL NADU |
8300833562
sajithasreekutty507@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committeee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
not applicable |
| Intervention |
Senecio aureus |
Sac lac 4 dose alternate hs
Globules once in 15 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
The patient was diagnosed with PCOS
The Female patient within the age group of 18 to 40 years
Persons who give valid consent for my study |
|
| ExclusionCriteria |
| Details |
Patients of age group below 17 years
Patients with other hormonal or metabolic disorders
Patients who had a history of any psychiatry disorders
Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pre and post-assessment of LH, FSH and Testosterone levels in Blood tests, USG of Abdomen and Pelvis |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Menstrual History Questionnaire |
1 year |
|
|
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)
|
08/09/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - all the data will be provided through email sajithasreekutty507@gmail.com
- For how long will this data be available start date provided 08-03-2027 and end date provided 08-03-2032?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
EFFECTIVENESS OF THE HOMOEOPATHIC MEDICINE SENECIO AUREUS IN THE TREATMENT OF POLYCYSTIC OVARIAN SYNDROME Polycystic ovarian syndrome is a complex endocrine and metabolic disorder affecting women of reproductive age this condition is also named as schleocystic ovaries multicystic ovaries androgen which is a male hormone elevated beyond its normal range in females affected with pcos polycystic ovarian syndrome is a condition characterized by elevated androgen levels menstrual irregularities and cysts on one or both ovaries in homoeopathy senecio aureus is the best medicine for functional amenorrhoea of young girls with backache the female patient with in the age group of 18 to 40 years patient diagnosed with pcos according to rotterdam criteria 2003 regularity of menstrual cycles changes in lh fsh and testosterone level in blood tests changes in ovarian morphology as observed on ultrasound the statistical analysis will be done using the paired t test |