| CTRI Number |
CTRI/2025/09/094022 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
29/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of individualised homoeopathic Medicine in the management of insomnia in post menopausal women |
|
Scientific Title of Study
|
Role of individualised homoeopathic medicine in the management of insomnia in post menopausal women an open label single arm prospective clinical 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 Pushplata kumari |
| Designation |
Post graduate trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy Department of organon of medicine opd no 14 and 31 GE block sector 3 salt lake kolkata west bengal 700106
Kolkata
WEST BENGAL
0
India |
| Phone |
6206360803 |
| Fax |
|
| Email |
pushplatakumari2722@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pushplata kumari |
| Designation |
Post graduate trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy Department of organon of medicine opd no 14 and 31 GE block sector 3 salt lake kolkata west bengal 700106
National Institute of Homoeopathy Department of organon of medicine opd no 14 and 31 GE block sector 3 salt lake Kolkata west bengal 700106
Kolkata
WEST BENGAL
700106
India |
| Phone |
6206360803 |
| Fax |
|
| Email |
pushplatakumari2722@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ompriya Mishra |
| Designation |
Professor |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy Department of Obstetrics and Gynaecology opd 31 GE block sector 3 salt lake kolkata west bengal 700106
National Institute of Homoeopathy Department of Obstetrics and Gynaecology opd 31 GE block sector 3 salt lake kolkata west bengal 700106
Kolkata
WEST BENGAL
700106
India |
| Phone |
8240359414 |
| Fax |
|
| Email |
drompriyanih@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy GE block sector 3salt lake kolkata west bengal 700106 |
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy GE block sector 3 salt lake kolkata west bengal 700106 |
| 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 |
| Dr Pushplata kumari |
National Institute of Homoeopathy |
National Institute of Homoeopathy Department of organon of medicine opd no 14 and 31 GE block sector 3 salt lake kolkata west bengal 700106
Kolkata
WEST BENGAL |
06206360803
pushplatakumari2722@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute of Homoeopathy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G470||Insomnia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised Homoeopathic medicine |
All the patient’s symptoms and written information
will be recorded in standard proforma that are used
in NIH Kolkata. All the cases will be repertorised with
Synthesis Repertory and final selection will be done
after consultation with materia medica. Dose and
frequency of the selected medicine will be as per the
Homoeopathic principles. Indicated Individualized
homoeopathic medicine will be prescribed. |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1.Women aged 45-60 years experiencing natural menopause, from all religion and socioeconomic background.
2. Insomnia accompanied by menopausal symptoms like hot flashes, night sweat, mood disturbance or hormonal imbalance.
3. Patients suffering from chronic insomnia for more than three months.
4. patients with ability to read write / understand Hindi or English or Bengali.
5. Patients who are willing to participate in the study and giving informed written consent. |
|
| ExclusionCriteria |
| Details |
1.Women with insomnia causes by underlying medical condition such as thyroid disorder, other serious chronic illness.
2.Patients on hormone replace therapy or other conventional medication superficially for insomnia.
3. Women with a history of severe psychiatric disorder such as major depression or bipolar disorder.
4.Patients not willing to take part in the study and not ready to give the written consent for the same.
5.Women undergoing induced menopause due to surgery. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Womens Health Initiative Insomnia Rating Scale (WHIIRS).The scale requires individuals to rate the quality of their sleep and the frequency with which they experience certain sleep problems, providing a total score that may be useful for both research and clinical purposes.A Brief 5 item scale evaluating insomnia symptoms.Response options range from 0 to 4, resulting in a possible total score of 20, with a score greater than 9 indicating clinically significant Insomnia. |
at the baseline and 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
MENOPAUSAL RATING SCALE:
The Menopause Rating Scale (MRS) is a health-related quality of life scale (HRQoL) it was developed in response to the lack of standardized scales to measure the severity of aging-symptoms and their impact on the HRQoL in the early 1990s.
The MRS consists of a list of 11 items (symptoms or complaints). Each of the 11 symptoms contained in the scale can get 0 (no complaints) or up to 4 scoring points (severe symptoms) depending on the severity of the complaints perceived by the women completing the scale |
at the baseline and 6 month |
|
|
Target Sample Size
|
Total Sample Size="37"
Sample Size from India="37"
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)
|
10/09/2025 |
| 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
|
This prospective, open label, single arm, clinical study will be conducted over 18 month at the National Institute of Homoeopathy, Kolkata, with each patient followed for six months. The study aim to evaluate the role of individualised Homoeopathic Medicine in the management of insomnia in post menopausal women. The primary objective is to determine the role of individualized homoeopathic medicine in the patients of insomnia in post- menopausal women by evaluating change in Women’s Health Initiative Insomnia rating scale after 6 months of treatment. The secondary objective is to evaluate change in Menopausal Rating Scale using individualized homeopathic medicine in insomnia in post-menopausal women associated after 6 months of treatment. A Women aged 45-60 years experiencing natural menopause, from all religion and socio- economic background. Insomnia accompanied by menopausal symptoms like hot flashes, night sweats, mood disturbance or hormonal imbalance. Patients suffering from chronic insomnia (difficulty initiating or maintaining sleep) for more than 3 months. Patients with ability to read /write /understand Hindi or English or Bengali. Patients who are willing to participate in the study and giving informed written consent will be included. Women with insomnia cause by underlying medical condition such as thyroid disorder, other serious chronic illness. Patients on hormone replacement therapy (HRT)or other conventional medication specifically for insomnia. Women with a history of severe psychiatric disorder such as major depression or bipolar disorder. Patients not willing to take part in the study and not ready to give the written consents for the same. Women undergoing induced menopause due to surgery will be excluded.Individualized homeopathic remedies will be selected based on repertorization (Synthesis Repertory) and Materia Medica, following Hahnemannian principles, with monthly follow-ups for six months to assess symptom changes. Treatment efficacy will be determined by comparing pre- and post-treatment of women’s health Initiative insomnia rating scale and menopausal rating scale. |