| 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
|
|
|
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
|
|
|
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. |