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CTRI Number  CTRI/2026/01/100600 [Registered on: 08/01/2026] Trial Registered Prospectively
Last Modified On: 08/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Assessment of Homeopathic treatment based on Individual Health pattern in perimenopausal women aged 40-55 years. 
Scientific Title of Study   A Clinical Study Of Miasmatic Predominance In Management Of Perimenopausal Women Of Age 40-55 Years- Case Series. 
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 Aqsa Shaikh  
Designation  MD Scholar 
Affiliation  Motiwala (National) Homoeopathic Medical College and Hospital, Nashik. 
Address  Department of Homoeopathic Philosophy, Motiwala (National) Homoeopathic Medical College and Hospital, Dhruv Nagar, Satpur Colony, Nashik

Nashik
MAHARASHTRA
422012
India 
Phone  8888237862  
Fax    
Email  aqsashaikh092@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Swati Patil 
Designation  Associate Professor ,Department of Organon of Medicine and homeopathic philosophy  
Affiliation  Motiwala (National) Homoeopathic Medical College and Hospital, Nashik. 
Address  Department of Homoeopathic Philosophy, Motiwala (National) Homoeopathic Medical College and Hospital, Dhruv Nagar, Satpur Colony, Nashik

Nashik
MAHARASHTRA
422012
India 
Phone  9158581569  
Fax    
Email  dr.swatibpatil@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Swati Patil 
Designation  Associate Professor ,Department of Organon of Medicine and homeopathic philosophy  
Affiliation  Motiwala (National) Homoeopathic Medical College and Hospital, Nashik. 
Address  Department of Homoeopathic Philosophy, Motiwala (National) Homoeopathic Medical College and Hospital, Dhruv Nagar, Satpur Colony, Nashik

Nashik
MAHARASHTRA
422012
India 
Phone  9158581569  
Fax    
Email  dr.swatibpatil@gmail.com  
 
Source of Monetary or Material Support  
Motiwala (National) Homoeopathic Medical College and Hospital, Dhruv Nagar, Satpur Colony, Nashik. 422012 
 
Primary Sponsor  
Name  Dr. Aqsa Shaikh 
Address  Motiwala (National) Homoeopathic Medical College and Hospital, Dhruv Nagar, Satpur Colony, Nashik. 422012 
Type of Sponsor  Other [Self ] 
 
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 Aqsa Shaikh   Motiwala Homeopathic Medical College and Hospital Nashik   Department of Organon of Medicine and Homeopathic Philosophy Dhruv Nagar Satpur Colony Nashik 422012
Nashik
MAHARASHTRA 		 8888237862

aqsashaikh092@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Cell Motiwala Homeopathic Medical College   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N958||Other specified menopausal and perimenopausal disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Single arm study 
Intervention  To study the effectiveness of Individualized homoeopathic Medicine in Perimenopausal complaints in age group 40 to 55 years.  After Homeopathic case taking Individualized homoeopathic will be prescribed. Dose and repetition of medicine will be done according to the individual case. Follow up will be taken after 15 days or as accessible. Assessment will be done at end of 6th follow-up with help of menopausal rating scale . 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  1.Females in age group 40 to 55 years
2.Females with any of the somatic, psychological and urogenital symptoms stated in MRS above 11.
3.LMP less than 1 year.
4.Not attained menopause
 
 
ExclusionCriteria 
Details  1.Females below 40 ages
2.Females above 55 ages
3.LMP more than 1 year.
4.Pregnant women.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To investigate predominant miasm in perimenopausal women age 40-55 years.  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To study the effectiveness of Individualized homoeopathic Medicine in Perimenopausal complaints in age group 40 to 55 years.  Baseline 
To identify the commonly prescribed homoeopathic medicine in Perimenopausal complaints in age group 40 to 55 years.   After 6 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   20/01/2026 
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   Title
A Clinical Study of Miasmatic Predominance in the Management of Perimenopausal Women (40–55 years): A Case Series

Background
Perimenopause (40–55 years) is marked by hormonal fluctuations causing somatic, psychological, and urogenital symptoms.
Conventional management is mainly symptomatic and may have adverse effects.
Homeopathy emphasizes individualization and miasmatic understanding for holistic care.

Research Gap
Limited studies on miasmatic predominance in perimenopausal women.
Insufficient evidence correlating miasms with perimenopausal symptomatology.
Need for systematic evaluation of miasmatic analysis in homeopathic management.

Research Question
Is there a significant association between miasmatic predominance and perimenopausal symptoms?

Hypothesis
There is a significant association between dominant miasm and perimenopausal symptoms.

Rationale
Perimenopause is clinically diagnosed without laboratory confirmation.
Hormonal and non-hormonal therapies have limitations and side effects.
Miasmatic approach may improve individualized and long-term outcomes in homeopathic practice.

Objectives
Primary
To identify the predominant miasm in perimenopausal women aged 40–55 years.
Secondary
To assess the effectiveness of individualized homeopathic treatment.
To identify commonly prescribed homeopathic medicines in perimenopausal cases.

Study Design & Methods
Design: Prospective case series
Sample size: 30 cases
Setting: OPD
Duration: 18 months
Sampling: Convenience sampling

Inclusion Criteria
Females aged 40–55 years
LMP < 1 year
Presence of symptoms as per MRS (>11)

Exclusion Criteria
Age <40 or >55 years
LMP >1 year
Pregnancy

Assessment Tools
Menopausal Rating Scale (MRS)
Case Record Format
Kent’s Repertory (Radar Opus)
R.P. Patel’s Chronic Miasms
MONARCH score for outcome assessment

Outcome Measures
Change in MRS score pre- and post-treatment
Identification of dominant miasm
Clinical improvement with individualized remedies

Ethical Considerations
Informed consent obtained
Confidentiality maintained

Expected Outcome
Identification of predominant miasm in perimenopausal women
Evidence supporting the role of individualized homeopathic treatment
Better understanding of miasmatic influence in perimenopause
 
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