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CTRI Number  CTRI/2025/02/080751 [Registered on: 18/02/2025] Trial Registered Prospectively
Last Modified On: 07/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Predominance of sycotic miasmatic manifestations in the cases of uterine fibroid 
Scientific Title of Study   A study to assess the predominance of sycotic miasmatic manifestations in the cases of uterine fibroid 
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 Varsha karanjia 
Designation  Postgraduate trainee 
Affiliation  State National Homoeopathic Medical college and Hospital lucknow 
Address  State National Homoeopathic Medical college and hospital Viraj khand 1 Gomti nagar Lucknow

Lucknow
UTTAR PRADESH
226010
India 
Phone  8604180554  
Fax    
Email  Karanjiav@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Om Prakash Singh 
Designation  Lecturer 
Affiliation  State National Homoeopathic Medical college and Hospital Lucknow 
Address  State National Homoeopathic Medical college and hospital Viraj khand 1 Gomti nagar Lucknow

Lucknow
UTTAR PRADESH
226010
India 
Phone  7839318990  
Fax    
Email  dr.opsingh10@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Varsha karanjia 
Designation  Postgraduate trainee 
Affiliation  State National Homoeopathic Medical College and Hospital Lucknow 
Address  State National Homoeopathic Medical college and hospital Viraj khand 1 Gomti nagar Lucknow

Lucknow
UTTAR PRADESH
226010
India 
Phone  8604180554  
Fax    
Email  Karanjiav@gmail.com  
 
Source of Monetary or Material Support  
Outpatient department of State National Homoeopathic Medical college and hospital,Lucknow 226010, Uttar pradesh 
 
Primary Sponsor  
Name  Dr Varsha karanjia 
Address  State National Homoeopathic Medical college and hospital Viraj khand 1 Gomti nagar 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
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 Varsha karanjia  State National Homoeopathic Medical college and hospital Lucknow  OPD 9 Department of Organon of Medicine and Homoeopathic Philosophy
Lucknow
UTTAR PRADESH 		 8604180554

Karanjiav@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of State National Homoeopathic Medical College and Hospital Lucknow   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D259||Leiomyoma of uterus, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualized Homoeopathic Medicine.  Patients qualifying to inclusion criteria will be included in the study. Proper case taking of all enrolled patients will be done in standardized case taking proforma which is being used in State National Homoeopathic medical college and hospital. Homoeopathic medicines will be prescribed to all patients after analysis and evaluation of symptoms and proper repertorization. Indicated homoeopathic remedy will be administered as decided appropriate to the case or condition in appropriate potency and doses. Medicines will be given oral route. Each case will be followed up at regular interval preferably at a period of 15 days or as per requirement. Patient will be studied for 6 months after enrolment in study. Outcome assessment of the patients will be carried out after 6 months of homoeopathic medication based on reduction in size of Uterine Fibroid using suitable diagnostic tool i.e. ultrasonography or transvaginal sonography or MRI or Hysteroscopy and Uterine Fibroid Symptoms Health Related Quality of Life Questionnaire. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  49.00 Year(s)
Gender  Female 
Details  1-Women with diagnosed cases of Uterine fibroid.
2-Presence of any of the symptoms such as
:Abnormal Uterine bleeding (profuse menstruation or intercyclic menstruation)
:Pelvic heaviness
:Pain during menstruation
:Pressure symptoms such as urinary frequency, constipation.
3-Participants must provide informed consent, adhere to study protocols, and attend scheduled visits. 
 
ExclusionCriteria 
Details  1-Pregnant and lactating women.
2- Presence of any other pelvic pathology.
3-Cases suffering from severe systemic illnesses or any other life
threatening conditions.
4- Patient undergoing any other treatment for fibroid.
5-Patient who are not willing to come for follow ups. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the predominance of sycotic miasmatic manifestations in
patients with uterine fibroid. 		 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the effectiveness of individualised homoeopathic medicine in reducing the size of uterine fibroid and improvement in quality of life using Uterine Fibroid Symptom Health Related Quality of Life Questionnaire(UFSQoL).  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)   20/02/2025 
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   Uterine fibroid or Leiomyomas are the most common benign tumors of the uterus and also the most common benign solid tumor in female. Histologically,the tumor is composed of smooth muscle and fibrous connective tissue. Uterine fibroid represent a significant gynecological concern worldwide of women during reproductive years. (Reproductive age 15-49years according to WHO). Although they are benign, mostly asymptomatic, they can have a significant influence on a woman’s health and quality of life, showing up as pelvic discomfort, or heavy menstrual bleeding and reproductive challenges such as recurrent pregnancy loss.
           At the end the study we may expect the dominance of sycotic miasm in cases of Uterine fibroid. The result of study will provide a deeper understanding of the role of the miasm in the pathophysiology and management of uterine fibroids, contributing to the scientific foundation of miasmatic theory in homeopathy. The miasmatic analysis can be helpful in anti-miasmatic prescription that will results in permanent restoration of health. By addressing the underlying miasmatic predisposition, the study emphasizes a holistic approach that treats the patient as a whole, rather than focusing solely on symptoms or pathology. 
 
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