| CTRI Number |
CTRI/2018/03/012571 [Registered on: 15/03/2018] Trial Registered Prospectively |
| Last Modified On: |
28/11/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Homoeopathic treatment of tumors in uterus |
|
Scientific Title of Study
|
Effectiveness of individualised homoeopathic medicines versus Aurum Muriaticum Natronatum in patients of uterine fibroid: An open-label randomized pragmatic clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1210-7895 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jasleen Luthra |
| Designation |
Postgraduate Trainee |
| Affiliation |
National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India |
| Address |
Dept of Homoeopathic Materia Medica, OPD room no. 13, Block GE, Sector III, Salt Lake, Kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
8076733716 |
| Fax |
|
| Email |
jasleen_luthra@ymail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Abhijit Chattopadhyay |
| Designation |
Professor and Head |
| Affiliation |
National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India |
| Address |
Dept of Homoeopathic Materia Medica, OPD room no. 13, Block GE, Sector III, Salt Lake, Kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
7003547446 |
| Fax |
|
| Email |
drac.nih@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abhijit Chattopadhyay |
| Designation |
Professor and Head |
| Affiliation |
National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India |
| Address |
Dept of Homoeopathic Materia Medica, OPD room no. 13, Block GE, Sector III, Salt Lake, Kolkata
WEST BENGAL
700106
India |
| Phone |
7003547446 |
| Fax |
|
| Email |
drac.nih@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India; Block GE, Sector III, Salt Lake, Kolkata 700106, 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
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Jasleen Luthra |
National Institute of Homoeopathy, Govt. of India |
Dept of Homoeopathic Materia Medica, OPD room no. 13, Block GE, Sector III, Salt Lake, Kolkata
Kolkata
WEST BENGAL |
8076733716
jasleen_luthra@ymail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D25||Leiomyoma of uterus, Uterine fibroids, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aurum Muriaticum Natronatum in centesimal or 50 millesimal potencies |
In centesimal scale, each dose consist of a single drop of Aurum Muriaticum natronatum (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 globule of poppy seed size (no. 10) will 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. Medicines to be taken orally on clean tongue in empty stomach. Duration of therapy: 6 months |
| Comparator Agent |
Individualized homoeopathic medicines in centesimal or 50 millesimal potencies |
In centesimal scale, each dose 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 globule of poppy seed size (no. 10) will 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. Medicines to be taken orally on clean tongue in empty stomach. Duration of therapy: 6 months |
|
|
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 and willing to continue any other alternative methods of contraception 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 in the study |
|
| ExclusionCriteria |
| Details |
1. Asymptomatic fibroids
2. Patients with calcified fibroid, coagulation disorders, extra uterine fibroid, uro-genital polyp, 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.
4. Patients with hemoglobin less than 7 gm/dl (severe anaemia)
5. Genito-urinary tract malignancy (suspected/diagnosed)
6. Patients desiring immediate surgical management for uterine fibroid
7. Previous history of myomectomy, myolysis, uterine artery embolisation, etc., for uterine fibroids
8. Patients desiring for childbearing within next year
9. Patients insisting to use OCPs
10. Patients with psychiatric diseases
11. Pregnancy and lactation
12. Cases suffering from uncontrolled systemic illness or life-threatening infections or any vital organ failure
13. Cases already undergoing homoeopathic treatment for any chronic purpose
14. Substance abuse and/or dependence
15. Self-reported immune-compromised state |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Uterine Fibroid Symptoms Quality of Life (UFS-QOL) questionnaire (translated Bengali version) |
Baseline, after 3 months and after 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number and/or size of uterine fibroid(s), as detected on pelvic ultrasound or transvaginal sonography |
Baseline, after 3 months and after 6 months |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
19/03/2018 |
| 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)
Modification(s)
|
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 homoeopath
[1]; however, there is an acute paucity of published research. In this open, randomized, pragmatic clinical
trial at National Institute of Homoeopathy, 62 patients will be randomized to
either empirically selected Aurum Muriaticum Natronatum (n=31) or individualized
homoeopathic medicines (n=31) to examine whether there exist any different
effect in treatment of uterine fibroids. Uterine Fibroids Symptoms Quality of
Life (UFS-QOL) questionnaire, and pelvic/transvaginal ultrasound measuring
number and size of fibroids(s) will be assessed at baseline, after 3 months,
and after 6 months. Comparative analysis between groups will be carried out to examine
group differences, if any. Results will be published in scientific journals. |