| CTRI Number |
CTRI/2024/12/078481 [Registered on: 23/12/2024] Trial Registered Prospectively |
| Last Modified On: |
14/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Role of Homoeopathic Medicines in the management of Vasomotor symptoms (hot flashes & night sweats) during perimenopause/menopause |
|
Scientific Title of Study
|
Effectiveness of Individualized Homoeopathic Medicines In the treatment of Vaso-Motor symptoms (hot flashes and night sweats) during Perimenopause/ Menopause: A single blind randomized controlled clinical trial |
| 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 Shivam Gupta |
| Designation |
PG Scholar |
| Affiliation |
Dr B R Sur Homoeopathic Medical College, Hospital & Research Centre, New Delhi - 110021 |
| Address |
Room No. 23, Ground floor, Department of Practice of Medicine, Dr B R Sur Homoeopathic Medical College, Hospital and Research Centre, Nanakpura, Motibagh, New Delhi - 110021
South West
DELHI
110021
India |
| Phone |
9953154917 |
| Fax |
|
| Email |
shivamgupta4917@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Archana Narang |
| Designation |
Professor, Department of Practice of Medicine |
| Affiliation |
Dr B R Sur Homoeopathic Medical College, Hospital & Research Centre, New Delhi - 110021 |
| Address |
Room No. 23, Ground floor, Department of Practice of Medicine, Dr B R Sur Homoeopathic Medical College, Hospital and Research Centre, Nanakpura, Motibagh, New Delhi - 110021
South West
DELHI
110021
India |
| Phone |
9868393288 |
| Fax |
|
| Email |
shmc.thyroidclinic@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivam Gupta |
| Designation |
PG Scholar |
| Affiliation |
Dr B R Sur Homoeopathic Medical College, Hospital and Research Centre, New Delhi - 110021 |
| Address |
Room No. 23, Ground floor, Department of Practice of Medicine, Dr B R Sur Homoeopathic Medical College, Hospital and Research Centre, Nanakpura, Motibagh, New Delhi - 110021
South West
DELHI
110021
India |
| Phone |
9953154917 |
| Fax |
|
| Email |
shivamgupta4917@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr B R Sur Homoeopathic Medical College, Hospital and Research Centre, Nanakpura, Motibagh, New Delhi - 110021, India |
|
|
Primary Sponsor
|
| Name |
Dr Shivam Gupta |
| Address |
Dr B R Sur Homoeopathic Medical College, Hospital and Research Centre, Nanakpura, Motibagh, New Delhi - 110021 |
| 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 Shivam Gupta |
Dr B R Sur Homoeopathic Medical College, hospital & Research Centre |
OPD & IPD of Dr B R Sur Homoeopathic Medical College, Hospital and Research Centre, Nanakpura, Motibagh, New Delhi - 110021
South West
DELHI |
9953154917
shivamgupta4917@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee Dr B R Sur Homoeopathic Medical College, Hospital & Research Centre, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N951||Menopausal and female climactericstates, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Identical looking Placebo |
Identical looking placebo will be given orally in globules form. Duration- 6 months. |
| Intervention |
Individualized Homoeopathic Medicines |
Individualized Homoeopathic Medicines will be administered in appropriate potencies, selected according to homoeopathic principles. The dose and repetition will be done as per the requirement of each case according to homoeopathic principles. Route of administration- Oral, in globules form. Duration- 6 months. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1. Consented Women between the age of 45-55years.
2. Volunteers experiencing climacteric symptoms of VASOMOTOR SYMPTOMS (HOT FLASHES AND NIGHT SWEATS)
3. Volunteers who had discontinued hormone replacement therapy or any other medical
treatment for climacteric symptoms at least three months prior to enrolment.
4. Diagnosed cases of VASOMOTOR SYMPTOMS (HOT FLASHES AND NIGHT SWEATS). |
|
| ExclusionCriteria |
| Details |
1.Volunteers women surgically or artificially induced menopause e.g. bilateral oophorectomyor total hysterectomy, any irradiation, chemotherapy, Drug treatment, or other process thatmay have resulted in menopausal symptoms.
2. Patients of malignancy.
3. Patient too sick for consultation.
4. Diagnosed case of mental illness / psychiatric/ other uncontrolled/ life threatening illnessaffecting quality of life/any organ failure.
5. Unwilling to take part and not giving consent to join the study. Patients unable to complywith the study protocol. |
|
|
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 |
| To determine the effectiveness of Individualized Homoeopathic Medicines in reducing hot flashes and improving the quality of life of menopausal women with VASOMOTOR SYMPTOMS (HOT FLASHES AND NIGHT SWEATS), assessed using the Hot Flash Related Daily Interference Scale (HFRDIS) |
At baseline and then after six months (24th week) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify the group of predominant homoeopathic medicines which are more useful in casesof VASOMOTOR SYMPTOMS (HOT FLASHES AND NIGHT SWEATS) |
1 year (12 months) |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 3 |
|
Date of First Enrollment (India)
|
25/12/2024 |
| 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="0"
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
|
This study compares the effectiveness of individualized homeopathic medicines and placebo in treating patients with VASOMOTOR SYMPTOMS (HOT FLASHES AND NIGHT SWEATS) during perimenopause/menopause, aged 45-55 years. Patients will be randomly assigned to receive either individualized homeopathic medicines or identical looking placebo. The study will measure the outcomes using Hot Flash Related Daily Interference Scale (HFRDIS). The primary goal is to compare the efficacy of these two approaches in managing VASOMOTOR SYMPTOMS (HOT FLASHES AND NIGHT SWEATS) during perimenopause/menopause, improving quality of life, and reducing disease severity. The results will provide valuable insights into the effectiveness of homeopathic approaches in treating VASOMOTOR SYMPTOMS (HOT FLASHES AND NIGHT SWEATS) during perimenopause/menopause.
|