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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  
Status 
Not Applicable 
 
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.
 
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