| CTRI Number |
CTRI/2025/09/095230 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
19/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic treatment to improve sleep in women after menopause |
|
Scientific Title of Study
|
A STUDY ON THE EFFECTIVENESS OF INDIVIDUALIZED HOMOEOPATHIC MEDICINES IN IMPROVING THE QUALITY OF SLEEP AMONG POST MENOPAUSAL WOMEN |
| 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 SUJITHA T |
| Designation |
JUNIOR RESIDENT DEPARTMENT OF PRACTICE OF MEDICINE |
| Affiliation |
WHITE MEMORIAL HOMOEO MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF PRACTICE OF MEDICINE,
WHITE MEMORIAL HOMOEO MEDICAL COLLEGE AND HOSPITAL
ATTOOR
VEEYANOOR POST
KANNIYAKUMARI DISTRICT
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
9042740640 |
| Fax |
|
| Email |
sujithatsn11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R RICHARD FRANKLIN |
| Designation |
PROFESSOR |
| Affiliation |
WHITE MEMORIAL HOMOEO MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF PRACTICE OF MEDICINE
WHITE MEMORIAL HOMOEO MEDICAL COLLEGE AND HOSPITAL
ATTOOR
VEEYANOOR POST
KANNIYAKUMARI DISTRICT
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
9486452262 |
| Fax |
|
| Email |
rrfranklin24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R RICHARD FRANKLIN |
| Designation |
PROFESSOR |
| Affiliation |
WHITE MEMORIAL HOMOEO MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF PRACTICE OF MEDICINE
WHITE MEMORIAL HOMOEO MEDICAL COLLEGE AND HOSPITAL
ATTOOR
VEEYANOOR POST
KANNIYAKUMARI DISTRICT
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
9486452262 |
| Fax |
|
| Email |
rrfranklin24@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF PRACTICE OF MEDICINE
WHITE MEMORIAL HOMOEO MEDICAL COLLEGE AND HOSPITAL
ATTOOR
KANNIYAKUMARI
TAMILNADU |
|
|
Primary Sponsor
|
| Name |
WHITE MEMORIAL HOMOEO MEDICAL COLLEGE AND HOSPITAL |
| Address |
ATTOOR, VEEYANOOR POST, KANNIYAKUMARI DISTRICT.
TAMILNADU - 629177 |
| Type of Sponsor |
Private 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 SUJITHA T |
WHITE MEMORIAL HOMOEO MEDICAL COLLEGE AND HOSPITAL |
DEPARTMENT OF PRACTICE OF MEDICINE,
WHITE MEMORIAL HOMOEO MEDICAL COLLEGE AND HOSPITAL
ATTOOR
VEEYANOOR POST
KANNIYAKUMARI DISTRICT
Kanniyakumari
TAMIL NADU |
9042740640
sujithatsn11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| WHITE MEMORIAL HOMOEO MEDICAL COLLEGE AND HOSPITAL ETHICS COMMITTEE |
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 |
Individualized Homoeopathic medicine |
A single homoeopathic medicine will be selected through proper Repertorization and Materia Medica and prescribed with suitable potency according to the patients susceptibility based on the Homoeopathic principles. The intervention will be administered with the intervals of 15 days once after follow ups. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Female |
| Details |
Females above 45yrs of age, who attained menopause naturally.
Cases who satisfying the points mentioned in verbal questionnaire as per National Institute for Health and Care Excellence guideline.
Cases satisfying Women’s Health Initiative Insomnia Rating Scale whose score is above 9 comprises of moderate and severe insomnia. |
|
| ExclusionCriteria |
| Details |
Patients who are having sleep disturbances due to inadequate sleep hygiene (daytime napping, irregular sleep-wake schedule, use of stimulants like caffeine or tobacco near bedtime), serious psychiatric conditions (schizophrenia, bipolar disorders, mania), neurologic disorders (myoclonus, dementia, parkinsonism).
Patients under any other serious systemic complications and illnesses that aggravates at night time.
Patients engaged in night shift work.
Patients who are under medications, drugs & stimulants that changes the sleep pattern. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The outcome will be assessed with the reduction in scores of Women’s Health Initiative Insomnia Rating Scale (WHIIRS)
01 to 04 Mild improvement
05 to 09 Moderate improvement
above 10 Marked improvement. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The improvement in the quality of sleep among Post menopausal women is considered to indicate that Individualized Homoeopathic medicines are effective. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
13/10/2025 |
| 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="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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sujithatsn11@gmail.com].
- For how long will this data be available start date provided 13-11-2026 and end date provided 13-11-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
AIM To evaluate the improvement in the quality of sleep among postmenopausal women after the administration of Individualized Homoeopathic medicines.
BACKGROUND AND JUSTIFICATION Sleep disorders occur to both males & females of all ages. But the various studies shown the results that the prevalence is higher in women than men of age above 45 years. There are multi factorial causes leading sleep disorders, among them menopausal insomnia is quite under-rated to get attention for getting proper treatment. Many clinical studies were conducted in modern medicine, but in Homoeopathy, many existing studies highlighting the role of Homoeopathic medicines in insomnia separately and in the management of menopause separately. Therefore, this study is justified to explore the potential of individualized Homoeopathic medicines in improving sleep quality in postmenopausal women, using Women’s Health Initiative Insomnia Rating Scale.
HYPOTHESIS Null hypothesis (H0): There is no significant improvement in the sleep quality among post-menopausal women after the administration of Individualized Homoeopathic medicines. Alternative hypothesis (H1): There is a significant improvement in the sleep quality among post-menopausal women after the administration of Individualized Homoeopathic medicines.
METHODOLOGY A sample of 40 cases will be selected based on purposive sampling. With the patient consent, detailed case taking will be done. The patient will be assessed at baseline with the (WHIIRS) Women’s Health Initiative Insomnia Rating Scale as pre assessment. After case taking, the totality of symptoms will be obtained through the analysis and evaluation of symptoms. With the help of proper repertorization and Homoeopathic Materia Medica, final selection of remedy will be done by Individualization. Then the Individualized Homoeopathic medicine will be prescribed with the proper dose, potency, and repetition of medicines according to the Homoeopathic principles. Follow up will be done 15 days once and every change in the quality of sleep will be assessed monthly once using Women’s Health Initiative Insomnia Rating Scale as post assessment. |