| CTRI Number |
CTRI/2018/04/013273 [Registered on: 13/04/2018] Trial Registered Prospectively |
| Last Modified On: |
13/04/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homeopathic treatment of tumors of uterus |
|
Scientific Title of Study
|
Validation of the translated Bengali version of Uterine Fibroid Symptom Quality of Life questionnaire (UFS-QOL) & open observational trial to evaluate effectiveness of individualized homoeopathic treatment of symptomatic uterine fibroids |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1212-0931 |
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
|
| Mahesh Bhattacharyya Homoeopathic Medical College & Hospital, Govt. of West Bengal |
| National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India |
| The Calcutta Homoeopathic Medical College & Hospital, Govt. of West Bengal |
|
|
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 |
| Sangita Saha |
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 |
9433849505
dr.sangita@rediffmail.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 |
Uterine fibroid, |
|
|
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 |
None |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Premenopausal women
2. Age 18-45 years
3. Uterine fibroids confirmed by pelvic and/or transvaginal ultrasonography
4. Presence of any of the symptoms such as abnormal uterine bleeding (profuse menstruation or intercyclic menstruation), pelvic heaviness, pain during menstruation, pain during intercourse, and pressure symptoms such as urinary frequency, constipation etc.
5. 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
6. Patients under hormonal replacement therapy (HRT) to be included after a washout period of 3 months
7. Patients with known but controlled systemic diseases with medication
8. Ability to read Bengali
9. Patients giving written consent to participate |
|
| ExclusionCriteria |
| Details |
1. Asymptomatic fibroids
2. Patients with calcified fibroid, coagulation disorders, extrauterine fibroid, polyp, cervical fibroid, any fibroid causing hydronephrosis, fibroid with solid ovarian mass
3. 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.
4. Patients with haemoglobin less than 7 gm/dl (severe anaemia)
5. Recent rapid growth of fibroid; i.e. doubling in size within last one to six months
6. Genito-urinary tract malignancy
7. Patients desiring immediate surgical management for uterine fibroid
8. Previous history of myomectomy, myolysis, uterine artery embolisation, etc., for uterine fibroids
9. Patients desiring for childbearing within next year
10.Patients insisting to use OCPs
11.Patients with psychiatric diseases
12.Pregnancy and lactation
13.Cases suffering from uncontrolled systemic illness or life-threatening infections or any vital organ failure
14.Cases already undergoing homoeopathic treatment for any chronic purpose
15.Substance abuse and/or dependence |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pelvic/transvaginal ultrasonographic measure of the fibroid(s) |
Baseline and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Translated Bengali version of Uterine Fibroid Symptom Quality of Life questionnaire (UFS-QOL) |
Baseline, 3 months 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
|
Uterine fibroids (myomas, fibromyomas or leiomyomas) are the most common, benign, monoclonal tumours of the smooth muscle cells and extracellular matrix proteins collagen and elastin found in the human uterus and are identified as the most common diagnosis associated with a hysterectomy. Uterine fibroids lead to nearly 600,000 hysterectomies performed each year in the USA and 37,000 myomectomies performed annually, nevertheless, epidemiological data on fibroid prevalence and incidence are limited and reliable population-based research is lacking. Therapeutic options include medical therapy, surgical interventions like hysterectomy (abdominal, vaginal and laparoscopic) and myomectomy (laparotomy, laparoscopic and hysteroscopic), and newer approaches, such as myolysis, focused ultrasound, transvaginal cryomyolysis and uterine artery embolisation (UAE). All conservative management options allow the possibility for new leiomyomas to form, and pre-existing small or undetected leiomyomas may exhibit significant growth, necessitating another treatment. The most frequently consulted alternative therapist for uterine fibroids is a homeopath; however, there is an acute paucity of published research. 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 Uterine Fibroids Symptoms Quality of Life (UFS-QOL) questionnaire will be tested. Results will be published in scientific journals. |