FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/03/082250 [Registered on: 12/03/2025] Trial Registered Prospectively
Last Modified On: 10/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Effectiveness of the individualised homoeopathic medicine in improving the quality of life of women with secondary infertility  
Scientific Title of Study   Role of the individualised homoeopathic medicine using 50 Millesimal potency in improving the quality of life of women with secondary infertility an open label non randomised clinical 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 Puja Barman 
Designation  post graduate trainee 
Affiliation  National Institute of Homoeopathy 
Address  opd no 14 and 31 Department of organon of medicine National Institute Of Homoeopathy GE block sector 3 salt lake kolkata west bengal 700106

Kolkata
WEST BENGAL
700106
India 
Phone  7002154173  
Fax    
Email  pujabarman2010@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Puja Barman 
Designation  post graduate trainee 
Affiliation  National Institute of Homoeopathy 
Address  opd no 14 and 31 Department of organon of medicine National Institute Of Homoeopathy GE block sector 3 salt lake kolkata west bengal 700106

Kolkata
WEST BENGAL
700106
India 
Phone  7002154173  
Fax    
Email  pujabarman2010@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ompriya Mishra 
Designation  Professor 
Affiliation  National Institute of Homoeopathy 
Address  opd no 31 Department of Obstetrics and Gynaecology National Institute of Homoeopathy GE block sector 3 salt lake kolkata west bengal 700106

Kolkata
WEST BENGAL
700106
India 
Phone  8240359414  
Fax    
Email  drompriyanih@gmail.com  
 
Source of Monetary or Material Support  
National Institute Of Homoeopathy GE block sector 3 salt lake kolkata west bengal 700106 
 
Primary Sponsor  
Name  National Instutute of Homoeopathy 
Address  National Institute Of Homoeopathy GE block sector 3 salt lake kolkata west bengal 700106 
Type of Sponsor  Government medical college 
 
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 Puja Barman  National Institute of Homoeopathy  National Institute Of Homoeopathy Department of organon of medicine opd no 14 and 31 GE block sector 3 salt lake kolkata west bengal 700106
Kolkata
WEST BENGAL 
7002154173

pujabarman2010@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
National Institute of Homoeopathy block sector 3 salt lake kolkata west bengal 700106   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N979||Female infertility, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualised Homoeopathic medicine  All the patient’s symptoms and written information will be recorded in standard proforma that are used in National institute if homoeopathy Kolkata and All the cases will be repertorised with Synthesis Repertory and final selection will be done after consultation with materia medica with Dose and frequency of the selected medicine will be as per the Homoeopathic principles Indicated Individualized homoeopathic medicine will be prescribed for 18 months  
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1.Patient diagnosed with secondary infertility and who score between 0-100 in fertility quality of life questionnaire (FertiQol).
2.Female patient with reproductive age 18-45.
3.Patient who can read/understand either English,Hindi, Bengali.
4.Patient who are willing to participate in study and giving written informed consent.
 
 
ExclusionCriteria 
Details  1.Patient whose husband have an abnormal semen analysis.
2.Patient who have never conceived a pregnancy before.
3.Patient who have already attained menopause.
4.Patient who are pregnant ,lactating mother, taking OCPs or post hysterectomy.
5.Patient who are taking medications for any chronic diseases.
6.Patient who are diagnosed with life threatening diseases, systemic illness, immune –compromised states, psychiatric illness, and malignancy.
7.Undergoing Homoeopathic treatment for any chronic disease within last 6 months.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The Fertility Quality of Life (FertiQoL) questionnaire.FertiQoL assesses the influences of fertility problems in diverse life areas.on general health, self-perceptions, emotions, partnership, family and social relationships, work life and future life plans. Additionally the optional FertiQoL Treatment module assesses the environment and tolerability of fertility treatment. It is hoped that FertiQoL will become the gold standard in measuring quality of life in people with fertility problems.36 FertiQoL items are rated according to 5 types of response scales.The response scales are: Very poor (0), poor (1), neither poor nor good (2), very good (4) Very dissatisfied.  At baseline and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Symptomatic relief of the patient can be assessed from the analysis of case records & follow up sheets of the patient
Ultrasonography plays a vital role in the evaluation diagnosis management of infertility in women It helps in evaluating the pathological findings

 
at the baseline after 6 month 
 
Target Sample Size   Total Sample Size="43"
Sample Size from India="43" 
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)   22/03/2025 
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  

This prospective open-label, non randomised ,clinical study will be conducted over 18 months at the National Institute of Homoeopathy, Kolkata, with each patient followed for six months. The study aims to evaluate the effectiveness of individualized homoeopathic treatment in improving the quality of life  of women with secondary infertility. The primary objective is to estimate the changes in Fertility quality of life of women in secondary infertility using individualised Homoeopathy medicine in 50 millesimal potency. Adults aged 18-45 years and patient diagnosed with secondary infertility and who score between 0-100 in fertility quality of life questionnaire (FertiQol), Patient who can read/understand either English, Hindi, Bengali. Patient who are willing to participate in study and giving written informed consent will be included. Patient whose husband have an abnormal semen analysis, Patient who have never conceived a pregnancy before, Patient who have already attained menopause, Patient who are pregnant ,lactating mother, taking OCPs or post hysterectomy, Patient who are taking medications for any chronic diseases, Patient who are diagnosed with life threatening diseases, systemic illness, immune –compromised states, psychiatric illness, and malignancy, Undergoing Homoeopathic treatment for any chronic disease within last 6 months will be excluded. Individualized homeopathic remedies will be selected based on repertorization (Synthesis Repertory) and Materia Medica, following Hahnemannian principles, with monthly follow-ups for six months to assess symptom changes. Treatment efficacy will be determined by comparing pre- and post-treatment of  fertility Quality of life questionaries.

 
Close