| CTRI Number |
CTRI/2024/09/073518 [Registered on: 06/09/2024] Trial Registered Prospectively |
| Last Modified On: |
03/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Usefulness of Oleum jecoris aselli in Management of Polycystic Ovarian Syndrome Comparing with individualized homeopathic medicines. |
|
Scientific Title of Study
|
Comparative study on the effectiveness of Oleum jecoris aselli and individualized homoeopathic medicines in the management of polycystic ovarian syndrome A double-blind randomized controlled trial. |
| 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 Kasi Bhavana |
| Designation |
POST GRADUATE TRAINEE,DEPARTMENT OF PRACTICE OF MEDICINE |
| Affiliation |
National Homoeopathy Research Institute in Mental health,Kottayam |
| Address |
National Homoeopathy Research Institute in Mental health (NHRIMH),Sacchivottamapuram (P.O),Kurichy,Kerala,686532
Kottayam
KERALA
686532
India |
| Phone |
9494757681 |
| Fax |
|
| Email |
k.bhavana1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Dastagiri |
| Designation |
Associate Professor R.O/H.S-2 |
| Affiliation |
National Homoeopathy Research Institute in Mental health,Kottayam |
| Address |
National Homoeopathy Research Institute in Mental health (NHRIMH),Sacchivottamapuram (P.O),Kurichy,Kerala,686532
Kottayam
KERALA
686532
India |
| Phone |
9000444409 |
| Fax |
|
| Email |
drdastagirinhrimh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr P Dastagiri |
| Designation |
Associate Professor.R.O(H)S-2 |
| Affiliation |
National Homoeopathy Research Institute in Mental health,Kottayam |
| Address |
National Homoeopathy Research Institute in Mental health (NHRIMH),Sacchivottamapuram (P.O),Kurichy,Kerala,686532
Kottayam
KERALA
686532
India |
| Phone |
9000444409 |
| Fax |
|
| Email |
drdastagirinhrimh@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Homoeopathy Research Institute in Mental health (NHRIMH),Kurichy,Kerala,India 686532 |
|
|
Primary Sponsor
|
| Name |
Dr Kasi Bhavana |
| Address |
National Homoeopathy Research Institute in Mental health ( NHRIMH),Sacchivottamapuram (P.O),Kurichy,kottayam 686532,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 Kasi Bhavana |
National Homoeopathy Research Institute in Mental Health (NHRIMH) |
Opd,ipd , peripheral camps and units,department of practice of medicine,national homoeopathy research institute in mental health,sacchivottamapuram (p.o),kurichy ,kerala 686532,india
Kottayam
KERALA |
9494757681
k.bhavana1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee,National Homoeopathy Research Institute, Kottayam |
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 |
| Comparator Agent |
Individualized Homoeopathic medicines
|
Patients who meet the inclusion criteria will be randomly assigned to one of two groups. Group A will receive Oleum jecoris aselli, while Group B will receive Individualized Homeopathic Medicine. The randomization process will be handled by the institute’s statistician, who will generate a randomization list using block randomization with a block size of four. This list will then be shared with the institute’s pharmacist, who will distribute the medicines based on the randomly generated numbers.
To minimize bias, both physicians and patients will be blinded to the group assignments. Patients in Group A will initially be prescribed Oleum jecoris aselli in a 6C potency (5 globules of size 40). The potency and dosage may be adjusted during follow-up visits as needed. If there is no improvement, the principal investigator will re-evaluate the case and may prescribe a higher potency of Oleum jecoris aselli or individualized homeopathic medicine.
The intervention will last for 10 months, with monthly follow-ups for all patients. Both groups will undergo a USG scan at the beginning and end of the study. Additionally, the PCOS Questionnaire, Modified Ferriman Gallway Score, and Global Acne Severity Score will be administered monthly. Patients in both groups will also be advised to follow lifestyle modifications, including a healthy diet and regular physical exercise or walking for at least 30 minutes daily. |
| Intervention |
Oleum jecoris aselli |
Patients who meet the inclusion criteria will be randomly assigned to one of two groups. Group A will receive Oleum jecoris aselli, while Group B will receive Individualized Homeopathic Medicine. The randomization process will be handled by the institute’s statistician, who will generate a randomization list using block randomization with a block size of four. This list will then be shared with the institute’s pharmacist, who will distribute the medicines based on the randomly generated numbers.
To minimize bias, both physicians and patients will be blinded to the group assignments. Patients in Group A will initially be prescribed Oleum jecoris aselli in a 6C potency (5 globules of size 40). The potency and dosage may be adjusted during follow-up visits as needed. If there is no improvement, the principal investigator will re-evaluate the case and may prescribe a higher potency of Oleum jecoris aselli or individualized homeopathic medicine.
The intervention will last for 10 months, with monthly follow-ups for all patients. Both groups will undergo a USG scan at the beginning and end of the study. Additionally, the PCOS Questionnaire, Modified Ferriman Gallway Score, and Global Acne Severity Score will be administered monthly. Patients in both groups will also be advised to follow lifestyle modifications, including a healthy diet and regular physical exercise or walking for at least 30 minutes daily. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Females aged between 18-45 years of age.
Patients presenting with oligomenorrhea or amenorrhea.
Patients with clinical evidence of hirsutism or acne.
Patients with positive findings of Polycystic changes in Ultrasonography. |
|
| ExclusionCriteria |
| Details |
Patients with known congenital adrenal hyperplasia, Cushing syndrome, and androgen secreting tumors
Patients with known thyroid dysfunction
Patients with known serious illness like large fibroids (greater than 7 cm) and endometrial malignancies
Patients seeking infertility treatment
Patients with known severe systemic illnesses like uncontrolled diabetes and hypertension
Patients under conventional treatment for PCOS
Pregnant and lactating women
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out the effectiviness of Oleum jecoris aselli compared to Individualized homoeopathic medicines in reducing ovarian volume in USG findings |
At the baseline and at the end of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To find out the effectiveness of oleum jecori aselli compared to individualized homoeopathic
medicine in reducing the number of cysts (peripherally arranged) in ovaries.
• To determine the effectiveness of Oleum jecori aselli compared to individualized homoeopathic
medicines in reducing the individual mean scores in PCOS Questionnaire.
• To evaluate hirsutism &acne using the Modified Ferriman Gallway score and global acne severity
score, before and after the homoeopathic intervention. |
The questionnaires and scales will be administered every month from baseline till the end of study |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
14/09/2024 |
| 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 a double-blind randomized control trial comparing Oleum jecoris aselli and Individualised Homoeopathic Medicines in management of polycystic ovarian syndrome for 18 months(8 months-enrolment and 10 month-follow up) that will be conducted in National Homoeopathic Research Institute in Mental Health, Kottayam, Dept of Practice of medicine.The primary outcome measure is to find out the effectiveness of oleum jecoris aselli compared to individualized homoeopathic medicines in reducing the ovarian volume in USG findings. |