| CTRI Number |
CTRI/2019/11/021998 [Registered on: 14/11/2019] Trial Registered Prospectively |
| Last Modified On: |
14/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homeopathic medicines in heavy menstrual bleeding due to tumors of uterus |
|
Scientific Title of Study
|
Efficacy of individualized homeopathic medicines in heavy menstrual bleeding due to uterine fibroids in reproductive age group: Double-blind, randomized, placebo-controlled clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1242-0153 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Suman Singh |
| Designation |
Postgraduate Trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Dept. of Organon of Medicine and Homeopathic Philosophy, OPD room no. 5 and 7, Block GE, Sector III, Salt Lake
Kolkata
WEST BENGAL
700106
India |
| Phone |
7890094491 |
| Fax |
|
| Email |
singhsuman1116@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ompriya Mishra |
| Designation |
Lecturer |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Dept. of Obstetrics and Gynecology, OPD room no. 4, Block GE, Sector III, Salt Lake
Kolkata
WEST BENGAL
700106
India |
| Phone |
8240359414 |
| Fax |
|
| Email |
drompriyanih@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ompriya Mishra |
| Designation |
Lecturer |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Dept. of Obstetrics and Gynecology, OPD room no. 4, Block GE, Sector III, Salt Lake
WEST BENGAL
700106
India |
| Phone |
8240359414 |
| Fax |
|
| Email |
drompriyanih@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, India |
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy |
| Address |
Block GE, Sector III, Salt Lake, Kolkata 700106, West Bengal, India |
| 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 |
| Suman Singh |
National Institute of Homoeopathy |
Dept. of Organon of Medicine and Homeopathic Philosophy, OPD room no. 5 and 7, Block GE, Sector III, Salt Lake
Kolkata
WEST BENGAL |
7890094491
singhsuman1116@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D259||Leiomyoma of uterus, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized homeopathic medicines in centesimal potencies, as decided appropriate to the case or condition |
Intervention is planned as administering individualized homeopathic medicines in centesimal potencies, as decided appropriate to the case or condition. In centesimal scale, each dose shall consist of 6-8 globules (no. 20) of cane sugar, medicated with the indicated medicine (preserved in 90% v/v ethanol) to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases. All medicines will be procured from a Good Manufacturing Practice (GMP)-certified firm. The patients will be advised to take iron rich diet. Duration of therapy: 3 months. |
| Comparator Agent |
Placebo, indistinguishable in appearance from verum |
This arm will receive placebo, indistinguishable in appearance from verum. Each dose of placebo shall consist of 6-8 globules (no. 20) of cane sugar moistened with rectified spirit, to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases. The patients will be advised to take iron rich diet. Duration of therapy: 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients suffering from heavy menstrual bleeding due to uterine fibroid (PBAC score 100 points or above indicate heavy menstrual bleeding)
2. Age: 18-45 years
3. Uterine fibroid detected on Trans-abdominal Sonography
4. Patients taking Oral Contraceptive Pills will be considered for the study after giving a wash-out period of 1 month
5. Patients giving written consent to participate in the study.
6. Literate patients, who can read and write in Bengali |
|
| ExclusionCriteria |
| Details |
1. Patients who are too sick for consultation.
2. Unwilling to take part and not giving consent to join the study.
3. Unable to read patient information sheet.
4. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life- threatening illness affecting quality of life or any organ failure.
5. Patients suffering from uro-genital polyp, uterine fibroid causing hydronephrosis, fibroid with solid ovarian mass, calcified fibroid.
6. Blood hemoglobin level less than 7gm/dl
7. Patients desiring immediate surgical management for uterine fibroid.
8. Pregnancy and lactation.
9. Substance abuse and/or dependence.
10. Self-reported immune-compromised state.
11. Undergoing homeopathic treatment for any chronic disease within last 6 months |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Highams Pictorial Blood Loss Assessment Chart (PBAC) scoring |
Baseline, every month, up to 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Size and number of the fibroids |
Baseline and 3 months |
| b. Uterine Fibroid Symptom And Health - Related Quality of Life (UFS-QOL) questionnaire |
Baseline and 3 months |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
18/11/2019 |
| 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
|
It has been estimated that at least 20 percent of women at the age of 30 have got fibroid in their wombs. In conventional therapy, drugs are used as a temporary palliation or may be used in rare cases, as an alternative to surgery. Though homeopathy has promising potentials in treating Heavy Menstrual Bleeding, it has remained mostly anecdotal rather than being evidence-based. Placebo-controlled randomized controlled trial has not been attempted yet in treatment of heavy menstrual bleeding due to uterine fibroids. This study is aimed to assess the efficacy of individualized homeopathic medicines in comparison with placebo in the above said condition. A double blind, randomized, placebo-controlled, two parallel arms clinical trial will be conducted on 68 patients at National Institute of Homoeopathy (NIH). Patients will be randomized to receive either individualized homeopathic medicines in centesimal potencies, or identical looking placebo. Irrespective of groups, all the randomized patients will be advised for iron rich diet. Duration of therapy will be 3 months. Higham’s Pictorial Blood Loss Assessment Chart (PBAC) scoring will be the primary outcome - measured at baseline, and every month, up to 3 months. Uterine fibroid size and number and Uterine Fibroid Symptom And Health - Related Quality of Life (UFS-QOL) questionnaire will be used as secondary outcomes - measured at baseline and after 3 months. Comparative analysis will be carried out to detect group differences. Results will be published in scientific journals. |