| CTRI Number |
CTRI/2018/04/013367 [Registered on: 19/04/2018] Trial Registered Prospectively |
| Last Modified On: |
19/04/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homeopathic treatment of multiple cysts in ovary |
|
Scientific Title of Study
|
An open observational clinical study of individualized homoeopathic treatment in polycystic ovarian syndrome (PCOS) and validation of the Bengali version of modified polycystic ovarian syndrome questionnaire (MPCOSQ) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1212-1043 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Subhranil Saha |
| Designation |
Postgraduate Trainee |
| Affiliation |
National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India |
| Address |
Department of Case Taking & Repertory, OPD room no. 11, Block GE, Sector III, Salt Lake, Kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
9831063837 |
| Fax |
|
| Email |
drsubhranilsaha@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Subhranil Saha |
| Designation |
Postgraduate Trainee |
| Affiliation |
National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India |
| Address |
Department of Case Taking & Repertory, OPD room no. 11, Block GE, Sector III, Salt Lake, Kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
9831063837 |
| Fax |
|
| Email |
drsubhranilsaha@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Subhranil Saha |
| Designation |
Postgraduate Trainee |
| Affiliation |
National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India |
| Address |
Department of Case Taking & Repertory, OPD room no. 11, Block GE, Sector III, Salt Lake, Kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
9831063837 |
| Fax |
|
| Email |
drsubhranilsaha@hotmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India |
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy Ministry of AYUSH Govt of India |
| Address |
Block GE, Sector III, Salt Lake, Kolkata 700106, West Bengal |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Mahesh Bhattacharyya Homoeopathic Medical College and Hospital Govt of west Bengal |
Drainage Canal Road, Doomurjala, Howrah 711104, West Bengal, India |
| The Calcutta Homoeopathic Medical College Hospital Govt of West Bengal |
265-266, APC Road, Kolkata 700009, West Bengal, India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Amila Modak |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Govt. of West Bengal |
OPD no. 5, Dept. of
Obstetrics &
Gynaecology, Drainage Canal Road,Doomurjala, Howrah
711104, West Bengal
Haora
WEST BENGAL |
9433432025
amilamodak@gmail.com |
| Ompriya Mishra |
National Institute of Homoeopathy, Govt. of India |
OPD no. 4, Dept. of
Obstetrics & Gynaecology, Block
GE, Sector III, Salt Lake, Kolkata 700106
Kolkata
WEST BENGAL |
9432496545
drompriyanih@gmail.com |
| Md Monowar Hossain |
The Calcutta Homoeopathic Medical College and Hospital, Govt. of West Bengal |
OPD no. 4, Dept. of
Obstetrics & Gynaecology, 265-266, APC Road, Kolkata
700009, West Bengal
Kolkata
WEST BENGAL |
9830760930
monowar.hossainmonowar.hossain@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Mahesh Bhattacharyya Homoeopathic Medical College Hospital |
Approved |
| Institutional Ethics Committee of National Institute of Homoeopathy |
Approved |
| Institutional Ethics Committee of The Calcutta Homoeopathic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Polycystic Ovarian Syndrome (PCOS), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Indicated homoeopathic
medicines in centesimal or fifty
millesimal potencies |
Indicated homoeopathic
medicines in centesimal or fifty millesimal potencies, as decided appropriate to the case or condition. In centesimal scale, each dose shall consist of a single drop of the indicated medicine (preserved in 90% v/v
ethanol) in 5 ml of distilled
water, to be taken orally;
dosage and repetition
depending upon the individual
requirement of the cases. In 50 millesimal scale, a single
medicated cane sugar globules
of poppy seed size (no. 10)
shall be dissolved in 90 ml
distilled water with addition of 2 drops of 90% v/v ethanol; 16 doses to be marked on the vial; each dose of 5 ml to be taken after 10 uniformly forceful downward strokes to the vial in 45 ml normal water in a clean cup, to stir well, to take 5 ml of
this liquid orally, and to discard rest of the liquid from the cup. All medicines will be procured from a Good Manufacturing Practice (GMP)-certified firm. All medicines should be taken on clean tongue in empty stomach. Along with medicines, the
patients will receive dietary
advices. Duration of therapy: 6 months. |
| Comparator Agent |
Nil |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Diagnosed PCOS as per Rotterdam diagnostic criteria [23] (developed in 2003 to aid clinicians in the systematic and accurate diagnosis of PCOS). It states that two of the following three criteria should be present for a diagnosis: a) oligo-ovulation or anovulation; b) clinical and/or biochemical signs of hyperandrogenism; and c) polycystic ovaries. Furthermore, the likelihood of other similar illnesses (such as Cushing’s syndrome) should first be systematically excluded. New criteria have recently been proposed by the Androgen Excess and PCOS Society, which suggest tighter definitions are required by focusing on only two criteria: a) hyperandrogenism (clinical hirsutism or biochemical hyperandrogenaemia, or both); and b) ovarian dysfunction (oligo-ovulation or anovulation, or polycystic ovaries, or both).
2. Age 18-45 years
3. Symptomatic for at least last 3 months
4. Patients taking oral contraceptive pills (OCPs) will be advised to stop pills till it exhaust for the ongoing cycle, followed by re-assessment of symptoms in the next cycle enrolment
5. Patients under hormonal replacement therapy (HRT) to be included after a washout period of 3 months
6. Patients with known but controlled systemic diseases with medication
7. Ability to read Bengali
8. Patients giving written consent to participate |
|
| ExclusionCriteria |
| Details |
1. Unevaluated gynaecological abnormalities; e.g. unexplained vaginal bleeding, cervical dysplasia, pelvic inflammatory diseases (PID) within one month, patients with suspicious adenomyosis, gross developmental defect or congenital abnormalities of the uterus etc.
2. Genito-urinary tract malignancy
3. Patients desiring immediate surgical management for PCOS
4. Patients insisting to use OCPs
5. Patients with psychiatric diseases
6. Pregnancy and lactation
7. Cases suffering from uncontrolled systemic illness or life-threatening infections or any vital organ failure
8. Cases already undergoing homoeopathic treatment for any chronic disease
9. Substance abuse and/or dependence
10. Self-reported immune-compromised state |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pelvic/transvaginal ultrasound and blood LH:FSH level |
Baseline and after 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Modified PCOS questionnaire (MPCOSQ); translated Bengali version |
Baseline, after 3 and 6 months |
| EQ-5D-5L questionnaire; validated Bengali version |
Baseline, after 3 and 6 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
23/04/2018 |
| 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) |
Open to Recruitment |
|
Publication Details
|
None yet; to be published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Polycystic ovarian syndrome (PCOS) is the most common endocrine disorder, affecting women of reproductive age, with an estimated prevalence of 4-25%. Its prevalence among infertile women is 15-20%. It is characterized by irregular menses, anovulation, clinical and/or biochemical signs of hyperandrogenism (including hirsutism, acne and alopecia), ovarian micropolycystic appearance and metabolic abnormalities, such as hyperinsulinaemia and obesity. As there is currently no cure, the management of PCOS is directed towards improving the patients’ health-related quality of life (HRQoL) by means of symptomatic alleviation and prevention of long-term complications (e.g. metabolic syndrome, cardiovascular diseases, type II diabetes mellitus etc.). Evidence based medical management emphasises a multidisciplinary approach for PCOS, as conventional pharmaceutical treatment may be contra-indicated, is often associated with side-effects and not effective in some cases. PCOS has earlier been reported to be one of the most frequently reported medical conditions in the obstetrics and gynaecology (O&G) outpatient of a homoeopathic hospital in West Bengal, and is also consistent with the finding from another O&G outpatient from another homoeopathy hospital in West Bengal. Physician-rated +2/+3 improvement was recorded in 58.6% and in 33.3% PCOS patients on a 7-point -3 to +3 Likert scale in the two hospitals. Thus PCOS was identified as one of the promising and priority research areas by this systematic documentation research. However, till date, clinical trials in this field have remained seriously compromised. In this open, observational, multicentric, pre-post comparison clinical trial, 100 patients will be given individualized homoeopathic medicines to examine treatment effect over 6 months. Prior to that, psychometric validity of the translated Bengali version of the Modified PCOS Questionnaire (MPCOSQ) will be tested. Results will be published in scientific journals.
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