| CTRI Number |
CTRI/2013/09/003983 [Registered on: 16/09/2013] Trial Registered Prospectively |
| Last Modified On: |
24/03/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homoeopathic intervention in polycystic ovarian syndrome |
|
Scientific Title of Study
|
Management of polycystic ovarian syndrome with homoeopathic intervention versus placebo -A randomized controlled pilot 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 RK Manchanda |
| Designation |
Director General |
| Affiliation |
Central Council of Research in Homoeopathy |
| Address |
Central Council of Research in Homoeopathy, 61-65, Institutional area, Janakpuri, New Delhi
West
DELHI
110058
India |
| Phone |
011-28525523 |
| Fax |
|
| Email |
dgccrh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Praveen Oberai |
| Designation |
Scientist 4 |
| Affiliation |
Central Council of Research in Homoeopathy |
| Address |
Central Council of Research in Homoeopathy, 61-65, Institutional area, Janakpuri, New Delhi
West
DELHI
110058
India |
| Phone |
011-28525749 |
| Fax |
|
| Email |
oberai.praveen@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chetna Deep Lamba |
| Designation |
Scientist 1 |
| Affiliation |
Central Council of Research in Homoeopathy |
| Address |
Central Council of Research in Homoeopathy, 61-65, Institutional area, Janakpuri, New Delhi
West
DELHI
110058
India |
| Phone |
011-28525749 |
| Fax |
|
| Email |
drchetnalamba@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council of Research in Homoeopathy |
|
|
Primary Sponsor
|
| Name |
Central Council of Research in Homoeopathy |
| Address |
61-65, Institutional area, Janakpuri, New Delhi 110058 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Padmalaya Rath |
Central Research Institute (H), NOIDA |
A – 1/1, Sector 24,
Opposite E.S.I. Hospital,
Noida, U.P. - 201301
Gautam Buddha Nagar
UTTAR PRADESH |
9811704560
drpadmalaya@gmail.com |
| Dr Hima Bindu Ponnam |
Drug Standardization Unit, Ext. Unit, Hyderabad |
Drug Standardization Unit (Extension),
Unit CCRH, Princess Durru Shevvar
Children & General Hospital, Purani haveli
Hyderabad, Andhra Pradesh - 500002
Hyderabad
ANDHRA PRADESH |
09490009899
drbindu_hima@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee of CCRH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Polycystic ovarian syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised homoeopathic medicine |
Medicine shall be given in Q, 6c, 30c, 200c or 1M potency as per the prescribing totality of the case. Mother tincture shall be prescribed only in persistent ammenorrhoea. The verum group will also be on lifestyle modification as per inclusion criteria. Total duration of therapy will be 6 months.The patients will be followed up at monthly interval and further treatment will be given as per the principles of homoeopathy. |
| Comparator Agent |
Placebo |
The placebo group will also be on lifestyle modification as per inclusion criteria. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
36.00 Year(s) |
| Gender |
Female |
| Details |
i.Female aged 18 to 36 years
ii. Oligomenorrhea (Intermenstrual period of more than 35 days for 3 consecutive
cycles)/amenorrhea for more than 3 months (two years after menarche)
iii.Ultrasound findings of Polycystic ovaries
The PCO should have at least one of the following: either 12 or more follicles measuring 2±9 mm in diameter or increased ovarian volume (>10 cm3). If there is evidence of a dominant follicle (>10 mm) or a corpus luteum, the scan should be repeated during the next cycle.
Only one ovary fitting this definition or a single occurrence of one of the above criteria is sufficient to define the PCO.
iv.Clinical evidence of hirsuitism (Ferriman score 8 and above)16 and/ or acne (acne global severity scale score 1 and above)
v.Body mass index (BMI) 23 and above
vi.Participants willing to adopt healthy diet and to take regular exercise (at least 30 minutes of exercise at least 5 days a week).
vii.Written Informed consent from the patient
|
|
| ExclusionCriteria |
| Details |
i. History of diabetes mellitus
ii. History of cushing disease
iii. History of hyperprolactinemia
iv. Untreated hypo or hyperthyroidism
v. History of adrenal hyperplasia and adrenal tumor
vi. Ovarian tumor
vii. Hyperthecosis
viii. Significant renal impairment
ix. History of intake of drugs aldactone/ metformin or history of OCP use or intake of drugs known to interfere with carbohydrate metabolism prior 4 weeks before enrolment
x. Pregnancy, breast feeding
xi. Cases with other systemic diseases like cardiovascular, endocrinal diseases or Systemic infections or on other treatment therapies
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • Establishment of regular menstrual cycle along with either ultrasonological improvement of PCO or improvement in hirsutism/ acne. |
Baseline and 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • To compare the changes in total and individual domain scores of PCOSQ in verum and placebo groups at monthly interval for 6 months. |
Every month for 6 months. |
| • To compare the changes in ultrasound reports of polycystic ovaries at entry and 6 months in verum and placebo groups. |
Baseline and 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
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/10/2013 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
The paper shall be published after completion of the study. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Polycystic Ovarian Syndrome (PCOS) is a complex metabolic, endocrine and reproductive disorder affecting approximately 5-10% of the female population in developed countries. However, recent findings from countries like China and India, which are undergoing rapid nutritional transitions due to westernized diets and lifestyle, indicate similar prevalence rates of PCOS. The conventional medical management of PCOS is also not without limitations. Homoeopathic treatment generally has no side effects and holistically treats the individual. Studies have evaluated the Homoeopathic treatment in PCOS. A double blind RCT by Sanchez et al and an observational study by Gupta et al indicate a positive role in PCOD. But these studies had their own limitations. Lifestyle modification including weight reduction has an important role in the management of PCOS. Therefore, the Council proposes to undertake a randomized placebo controlled pilot study to evaluate the efficacy of homoeopathic intervention in the management of PCOS along with lifestyle management with the following objectives- Primary Objective: · To determine the feasibility of the study to evaluate the efficacy of homoeopathic intervention as compared with placebo in PCOS in establishing the menstrual regularity with either ultrasonological improvement of PCO or improvement in hirsutism/ acne. Secondary Objectives: · To assess the changes in ultrasound reports of polycystic ovaries in verum and placebo groups. - To assess the changes in the total and individual domain scores of PCOSQ. |