| CTRI Number |
CTRI/2025/05/087047 [Registered on: 16/05/2025] Trial Registered Prospectively |
| Last Modified On: |
15/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An interventional clinical trial to see effect of homoeopathic medicine in reproductive age group female with abnormal uterine bleeding |
|
Scientific Title of Study
|
EFFECT OF INDIVIDUALIZED HOMOEOPATHIC MEDICINES IN FIFTY MILLESIMAL POTENCY IN ABNORMAL UTERINE BLEEDING WITH IT’S MIASMATIC ANALYSIS IN REPRODUCTIVE AGE GROUP FEMALES: A PROSPECTIVE STUDY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nayab Amir |
| Designation |
Postgraduate Trainee |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
Dept. Of Organon of Medicine, OPD room no. 19, The Calcutta Homoeopathic Medical College and Hospital
265,266 Acharya Prafulla Chandra Road
Kolkata
Kolkata
WEST BENGAL
700009
India |
| Phone |
7980360307 |
| Fax |
|
| Email |
nayabamir55@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aloke Kumar Ghosh |
| Designation |
Professor and head |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
Dept. Of Organon of Medicine, OPD room no. 19, The Calcutta Homoeopathic Medical College and Hospital
265,266 Acharya Prafulla Chandra Road
Kolkata
Kolkata
WEST BENGAL
700009
India |
| Phone |
9836584268 |
| Fax |
|
| Email |
dralok1974ghosh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nayab Amir |
| Designation |
Postgraduate Trainee |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
Dept. Of Organon of Medicine, OPD room no. 19, The Calcutta Homoeopathic Medical College and Hospital
265,266 Acharya Prafulla Chandra Road
Kolkata
Kolkata
WEST BENGAL
700009
India |
| Phone |
7980360307 |
| Fax |
|
| Email |
nayabamir55@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Calcutta Homoeopathic Medical College and Hospital,265,266 Acharya Prafulla Chandra Road Kolkata 700009, West Bengal |
|
|
Primary Sponsor
|
| Name |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
265,266 Acharya Prafulla Chandra Road Kolkata 700009, 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 |
| Nayab Amir |
The Calcutta Homoeopathic Medical College and Hospital |
265, 266, Acharya Prafulla Chandra Road, Kolkata 700009, West Bengal
Kolkata
WEST BENGAL |
7980360307
nayabamir55@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N939||Abnormal uterine and vaginal bleeding, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized homoeopathic medicines in fifty millesimal potency with concomitant care. |
Intervention was planned as administering indicated homeopathic medicines in 50
millesimal potencies, as decided appropriate to the case or condition. In 50
millesimal potencies, one medicated globule of no.10 is to be dissolved in 100 ml
of distilled water, 5 minims of rectified spirit are added to it and mixed well to make
7 doses or as required. After 10 uniform forceful downward strokes to the vial, each
dose of 15ml is to be added in 45ml normal water in a clean cup and to be stirred
well, from the mixture 5ml is to be taken orally on clean tongue in empty stomach,
and rest of the mixture is to be discarded. Dosage and repetition will be done
depending upon the individual requirement of the case. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
1) Patients fitting in the definition of AUB cases [(ICD-11-GA2Y)] more than 6 months.
2) Patients with age varying from 18 to 49 years.
3) Patients who can read or understand English, Bengali, Hindi. |
|
| ExclusionCriteria |
| Details |
1) Patient not willing to participate in study.
2) Pregnant, Puerperal women, Lactating mothers.
3) Patients having IUCD in situ.
4) Non-menstrual & non uterine causes for bleeding (Foreign bodies, genital malignancy,
abortion, post coital).
5) Patients having haemoglobin less than 8 gm/dl [44].
6) Patients already undergoing any other treatment for AUB or any chronic diseases especially
in last 6 weeks.
7) Patients already diagnosed of unstable psychiatric illness or other systemic diseases
affecting quality of life.
8) Patients having any habits of substance abuse and addiction.
9) Simultaneous participation in any other clinical trial. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To see changes in Pictorial Blood Assessment Chart (PBAC) Score after 6 months
of intervention. |
At baseline, every 4 weeks, up to 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To detect the predominant miasm in cases with Abnormal uterine bleeding (AUB).
2. Changes in Short Form-36 Health Survey Questionnaire 1.0.
3. To ascertain and shortlist the most frequently indicated homoeopathic medicines in
the treatment of AUB. |
At baseline, every 4 weeks, up to 6 months |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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
|
N/A |
|
Date of First Enrollment (India)
|
29/05/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Abnormal uterine bleeding (AUB;ICD-11-GA2Y)
is a most common gynaecological symptom that describes irregularities in the menstrual cycle
involving frequency, regularity, duration, and volume of flow outside of pregnancy. A normal
menstrual cycle has a frequency of 24 to 38 days and lasts 2 to 7, with 5 to 80 millilitres of blood
loss. Variations in any of these 4 parameters constitute abnormal uterine bleeding. It encompasses
heavy menstrual bleeding, irregular menstrual bleeding and intermenstrual bleeding. Among
them, HMB is the common conditions which affects 14-25% of women of reproductive age, with
menorrhagia as the most common presentation about 32% followed by polymenorrhoea in 14%,
metrorrhagia in 9% and menometrorrhagia in 4% of patients. AUB accounts for one third of
outpatients who visits gynaecology OPD. This open label, single arm, prospective study is aimed to evaluate the role of Individualised Homoeopathic Medicines (IHMS) in fifty millesimal scale in the management of abnormal uterine bleeding in reproductive age group females(18 to 49 years). Study is planned to be conducted at The Calcutta Homoeopathic Medical College and Hospital. Study has a target to achieve a sample of 34 patients. Primary outcome assessment will be done by using PBAC Score and secondary outcome is to see changes in Short Form-36 Health Survey Questionnaire 1.0; to detect the predominant miasm in cases with Abnormal uterine bleeding (AUB); and to shortlist the most frequently indicated homoeopathic medicines in
the treatment of AUB; all to be measured at baseline, and every month up to 6 months. The score obtained by the patients will be compared and result will be analysed as per appropriate statistical methods and interference will be done thereafter. |