| CTRI Number |
CTRI/2026/01/102287 [Registered on: 28/01/2026] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
Homoeopathic medicines Cimicifuga racemosa and Sanguinaria canadensis in the treatment of Perimenopausal syndrome |
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Scientific Title of Study
|
Assessing the effectiveness of Homoeopathic medicines Cimicifuga racemosa and Sanguinaria canadensis in the management of Perimenopausal Syndrome - A comparative 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 Ananyaa A G |
| Designation |
PG Scholar |
| Affiliation |
Government Homoeopathic Medical College and Hospital Bengaluru |
| Address |
Government Homoeopathic Medical College and Hospital Dr Siddhaiah Puranik Road KHB Colony Stage 1 Basaveshwara Nagar Bengaluru
Bangalore KARNATAKA 560079 India |
| Phone |
7349430509 |
| Fax |
|
| Email |
ananyaag24@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Renuka S Patil |
| Designation |
Head of Department and Professor |
| Affiliation |
Government Homoeopathic Medical College and Hospital |
| Address |
Government Homoeopathic Medical College and Hospital Dr Siddhaiah Puranik Road KHB colony stage 1 Basaweshwar nagar Bengaluru
Bangalore KARNATAKA 560079 India |
| Phone |
9945887471 |
| Fax |
|
| Email |
renukasiddrampatil@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Ananyaa A G |
| Designation |
PG Scholar |
| Affiliation |
Government Homoeopathic Medical College ad Hospital Bengaluru |
| Address |
Government Homoeopathic Medical College and Hospital Dr Siddhaiah Puranik Road KHB colony stage 1 Basaveshwar Nagar Bengaluru
Bangalore KARNATAKA 560079 India |
| Phone |
7349430509 |
| Fax |
|
| Email |
ananyaag24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Ananyaa A G
Government Homoeopathic Medical College and Hospital Dr Siddhaiah Puranik Road Basaweshwar nagar Bengaluru Karnataka India 560079 |
|
|
Primary Sponsor
|
| Name |
Dr Ananyaa A G |
| Address |
Government Homoeopathic Medical College and Hospital Dr Siddhaiah Puranik Road Basaweshwar Nagar Bengaluru Karnataka India 560079 |
| Type of Sponsor |
Other [Principal Investigator] |
|
|
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 Ananyaa A G |
Government Homoeoapthic Medical College and Hospital |
Government Homoeoapthic Medical College and Hospital Dr Siddhaiha Puranik Road Basaweshwar nagar Bengaluru 560079 Ground Floor Room no 22 Bangalore KARNATAKA |
7349430509
ananyaag24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Homoeopathic Medical College and Hospital Bengaluru |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N959||Unspecified menopausal and perimenopausal disorder, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cimicifuga racemosa and Sanguinaria canadensis |
One group acts as a comparator for the another group |
| Intervention |
Cimicifuga racemosa and Sanguinaria canadensis |
Study subjects who will be diagnosed with Perimenopausal Syndrome based on history clinical symptoms and Menopausal Rating Scale. These subjects will then be randomly divided into 2 groups. Follow up of the subjects will be analysed using Menopausal Rating Scale.Random assignment of Cimicifuga racemosa and Sanguinaria canadensis will be done for a period of 6 months. Follow up will be done once in a month for a period of 6 months. Potency and repetition of the doses will be done according to the requirement of the case as per Homoeopathic principles |
|
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Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Subjects who are willing to participate as volunteers and who have signed the informed consent.
Women diagnosed with perimenopausal syndrome.
Women who are screened on the basis of Menopausal Rating Scale with a score 5 and above.
Women between the age of 40-55 years. |
|
| ExclusionCriteria |
| Details |
Subject who had undergone artificial menopause by surgical or radiation therapy.
Subjects with any diagnosed systemic illness. |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in the symptoms of Perimenopausal Syndrome and Scores of Menopausal Rating Scale |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Overall well being
Sleep quality
Emotional well being |
6 months |
|
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
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)
|
04/02/2026 |
| 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
|
NEED FOR THE STUDY Menopause is defined as the period marked by the permanent cessation of the menstrual cycle, signifying the end of reproductive life in a woman. Diagnosis of menopause is confirmed by 12 consecutive months of amenorrhea. The symptoms that crop up during this phase are due to loss of follicular ovarian activity and subsequent estrogen deficiency.Perimenopause, or the menopausal transition phase, is a period during which there is a decline in hormonal activity of the ovary, which results in anovulation and eventual cessation of menstruation. It spans for 3 to 4 years before menopause and continues up to 1 year following menopause.Symptoms of perimenopausal syndrome include irregular menstrual cycles, hot flushes, night sweats, urogenital symptoms, sleep disorders, mood swings, low sexual drive, irritability and memory issues. The average age of natural menopause in India is around 47 years. Menopause is a crucial milestone in the life of every woman. Studies have shown that women experience physical well as psychological distress during the perimenopausal period, which affects their quality of life. Homoeopathic medicines are effective in the management of Menopausal and Perimenopausal disorders. Homoeopathic literature has mentioned that Cimicifuga racemosa has been indicated for complaints that arise during the menopausal period. Also, Cimicifuga racemosa has a marked action on ovarian and uterine disorders. Sanguinaria canadensis has been well indicated for menopausal complaints in various literature. Also, an observational study showed that Sanguinaria canadensis, Belladonna, Lachesis, Sulphur and Sepia were effective in the management of hot flushes during menopause. The full potential of these two remedies for perimenopausal conditions remains under-researched till date. Hence, this study intended to validate and compare the efficacy of Sanguinaria canadensis and Cimicifuga racemosa in the management of Perimenopausal Syndrome. RESEARCH QUESTION Is there any significant difference in the effectiveness of Homoeopathic medicines Cimicifuga racemosa and Sanguinaria canadensis in the management of Perimenopausal Syndrome? NULL HYPOTHESIS H0 There may not be significant difference between Homoeopathic medicines Cimicifuga racemosa and Sanguinaria canadensis in the management of Perimenopausal Syndrome. RESEARCH HYPOTHESIS H1 There may be significant difference between Homoeopathic medicines Cimicifuga. racemosa and Sanguinaria canadensis in the management of Perimenopausal Syndrome.
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