| CTRI Number |
CTRI/2024/06/068464 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
01/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic Management of menopausal Symptoms. |
|
Scientific Title of Study
|
An Interventional Study Using Individualized Homoeopathic Medicines With Miasmatic Approach in Management of Post-Menopausal Syndrome. A Single Arm Open Label 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 |
Dr Kanupriya |
| Designation |
Post Graduate Trainee |
| Affiliation |
State National Homoeopathic Medical College And Hospital, 1-Viraj Khand, Gomti Nagar, Lucknow (UP) |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy, State National Homoeopathic Medical College and Hospital, 1-Viraj Khand,
Gomti Nagar, Lucknow (UP)
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
9870611887 |
| Fax |
|
| Email |
kanupriyachauhan049@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amitesh Kumar Singh |
| Designation |
Lecturer |
| Affiliation |
State National Homoeopathic Medical College And Hospital, 1-Viraj Khand, Gomti Nagar, Lucknow (UP) |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy, State National Homoeopathic Medical College and Hospital, 1-Viraj Khand,
Gomti Nagar, Lucknow (UP)
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8874073232 |
| Fax |
|
| Email |
dramitesh04@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amitesh Kumar Singh |
| Designation |
Lecturer |
| Affiliation |
State National Homoeopathic Medical College And Hospital, 1-Viraj Khand, Gomti Nagar, Lucknow (UP) |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy, State National Homoeopathic Medical College and Hospital, 1-Viraj Khand,
Gomti Nagar, Lucknow (UP)
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8874073232 |
| Fax |
|
| Email |
dramitesh04@gmail.com |
|
|
Source of Monetary or Material Support
|
| State National Homoeopathic Medical College and Hospital, 1-Viraj Khand,
Gomti Nagar, Lucknow- 226010 (UP), India. |
|
|
Primary Sponsor
|
| Name |
Dr Kanupriya |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy, State National Homoeopathic Medical College and Hospital, 1-Viraj Khand,
Gomti Nagar, Lucknow- 226010 (UP), India. |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Dr Kanupriya |
State National Homoeopathic Medical College And Hospital |
OPD No.- 6, State National Homoeopathic Medical College And Hospital, 1-Viraj Khand,
Gomti Nagar, Lucknow- 226010 (UP), India.
Lucknow
UTTAR PRADESH |
9870611887
kanupriyachauhan049@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee State National Homoeopathic Medical College And Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N959||Unspecified menopausal and perimenopausal disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicines |
Intervention- The individualized homoeopathic medicine will be selected according to the
totality of symptoms.
Dosage- Medicine will be given in varying potencies of centesimal scale in globules
as identified from detailed case taking. Each dose shall consist of 4-5 globules of cane sugar medicated with single medicine.
Route of administration- The medicine will be administered via Oral route.
The patient will be called for follow up after every 15 days and the final assessment will be done after 6 months. At every follow up after reexamining the case it will be decided whether the patient will receive a dose of individualized homoeopathic medicine or placebo. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
1. Female patient who have attained menopause i.e. amenorrhea for last 12
consecutive months.
2. Female patient presenting with symptoms of Post-menopausal syndrome i.e.
mood swings, hot flushes, insufficient sleep, and genitourinary problems/sexual
dysfunction etc.
3. Diagnostic criteria are mainly on clinical presentation.
4. Females willing to participate in study and ready to provide informed written
consent. |
|
| ExclusionCriteria |
| Details |
1. Female patients who have undergone artificial menopause or surgical menopause
and premature menopause.
2. Females suffering from any other systemic disorders such as diabetes mellitus,
cardiac disorder, thyroid dysfunction and established case of mental illness etc.
3. Women having anti-depressents, HRT etc. or any other medication that may
influence the outcome of study.
4. Patients with post-menopausal bleeding, malignancy and uterine fibroid.
5. Females not willing to participate in study.
6. Patients participating in any other ongoing study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To identify the underlying prevalent miasm. |
24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the menopause rating scale at baseline and after 3 months to assess the utility of individualized homoeopathic medicine. |
4 weeks, 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 1 |
|
Date of First Enrollment (India)
|
12/06/2024 |
| 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 Yet Recruiting |
| 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
|
This
is a single arm, open label, interventional study which aims to assess the utility
of individualized homoeopathic medicine with miasmatic approach in management of
post-menopausal syndrome. Individualized homoeopathic medicine will be
prescribed in centesimal scale after detailed case taking. Menopause rating
scale will be calculated every month up to 6 months. The difference between the
menopause rating scale before and after the treatment will be compared and analyzed.
Hormone replacement treatment gained a lot of popularity and was previously advised for
menopause symptoms. Nonetheless, research from the Women’s Health Initiative revealed a
higher risk of Alzheimer’s and cardiovascular disease. When menopause approaches, an
estimated 80% of women have physical or psychological symptoms that
alter their quality of life. Homoeopathic management can be cost effective compared to conventional method.
Therefore, the present study is undertaken to explore how
individualized homoeopathic medicines selected on the basis of miasmatic
approach can prove to be useful in the management of Post menopausal syndrome. |