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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 
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  
Name  Address 
NIL  NIL 
 
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 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N959||Unspecified menopausal and perimenopausal disorder,  
 
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 
 
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. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
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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