| CTRI Number |
CTRI/2025/08/092462 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
05/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study on the Effects of Individualized Homeopathic Treatment in Women Facing Long-Term Fertility Problems Using Emotional and Sensory Health Measures |
|
Scientific Title of Study
|
An Open-Label Single-Arm Prospective Study to Observe Individualized Homeopathic Treatment Outcomes in Women with Chronic Fertility Issues Using Fertility Problem Inventory and Two-Point Discrimination |
| 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 G Senthil Kumaran |
| Designation |
Assistant Professor |
| Affiliation |
Venkateswara Homoeopathic Medical College and Hospital |
| Address |
Department of Homoeopathic Pharmacy,
4/11, Samayapuram Main Road,
Karambakkam, Porur, Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9486875128 |
| Fax |
|
| Email |
senthilbhms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Sandhya |
| Designation |
Professor |
| Affiliation |
Venkateswara Homoeopathic Medical College and Hospital |
| Address |
Department of Community Medicine,
4/11, Samayapuram Main Road,
Karambakkam, Porur, Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
600116 |
| Fax |
|
| Email |
drsandhyakalidas@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Sandhya |
| Designation |
Professor |
| Affiliation |
Venkateswara Homoeopathic Medical College and Hospital |
| Address |
Department of Community Medicine,
4/11, Samayapuram Main Road,
Karambakkam, Porur, Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
600116 |
| Fax |
|
| Email |
drsandhyakalidas@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Venkateswara Homoeopathic Medical College and Hospital,
4/11, Samayapuram Main Road, Karambakkam, Porur, Chennai - 600116 |
|
|
Primary Sponsor
|
| Name |
Venkateswara Homoeopathic Medical College and Hospital |
| Address |
4/11, Samayapuram Main Road, Karambakkam, Porur, Chennai - 600116 |
| Type of Sponsor |
Private 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 G Senthil Kumaran |
Venkateswara Homoeopathic Medical College and Hospital |
Department of Homoeopathic Pharmacy,
4/11, Samayapuram Main Road, Karambakkam, Porur, Chennai
Chennai
TAMIL NADU |
9486875128
senthilbhms@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Venkateswara Homoeopathic Medical College and Hospital Institutional Ethics Committee for Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N970||Female infertility associated withanovulation, (2) ICD-10 Condition: N978||Female infertility of other origin, (3) ICD-10 Condition: N971||Female infertility of tubal origin, (4) ICD-10 Condition: N972||Female infertility of uterine origin, (5) ICD-10 Condition: N979||Female infertility, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homeopathic Remedy in Centisimal or LM Potency |
According to each case, as per the principles of classical homoeopathy (totality of symptoms and miasmatic background), the indicated remedy will be selected. Medicines will be administered in either Centisimal or LM (Q) potencies based on individual susceptibility. The remedy will be prepared in a 100 ml aqueous solution with succussion before each dose. A 5 ml dose will be administered orally once or twice daily, based on clinical need, for a duration of 6 weeks. Adjustments in remedy, potency, or repetition may be made during follow-up as per homoeopathic principles. |
| Comparator Agent |
Not Applicable – Single Arm Study |
This is a single-arm interventional study. No comparator, placebo, or standard allopathic treatment is included. Outcome measures will be compared to each participant’s baseline status using validated tools (Fertility Problem Inventory and Two-Point Discrimination). |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Females aged 20 to 45 years
Diagnosed with primary or secondary infertility for above 12 months
Regular sexual activity without contraception
Willing to provide informed consent |
|
| ExclusionCriteria |
| Details |
Current use of other fertility therapies
Structural abnormalities requiring surgical correction
Diagnosed endocrine disorders not under control
Pregnancy during screening |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in Fertility Problem Inventory (FPI) total and subdomain scores from baseline to week 6
Domains: Social concern, sexual concern, relationship concern, need for parenthood, and rejection of child-free lifestyle |
baseline to week 6 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Two-Point Discrimination (TPD) threshold from baseline to week 6 at selected dermatomes |
baseline to week 6 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/08/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 is a prospective, open-label, single-arm interventional study designed to observe the outcomes of individualized homeopathic treatment in women with chronic fertility issues. The study will include women aged 20–45 years who have been diagnosed with infertility (primary or secondary) for more than 12 months.
Participants will receive individualized homeopathic medicines selected based on classical principles, including totality of symptoms and miasmatic analysis. Remedies will be prescribed in centesimal or LM (Q) potencies according to the physician’s discretion. Treatment will continue for a period of 6 weeks, with follow-ups every two weeks.
Outcome measures will include changes in the Fertility Problem Inventory (FPI), assessing psychosocial stress related to infertility, and Two-Point Discrimination (TPD) scores, evaluating sensory perception possibly related to pelvic or neurological involvement. This multidimensional approach aims to document both emotional and somatosensory changes resulting from individualized homeopathic intervention.
No placebo or control group is involved; each participant serves as her own control through baseline comparison. This study is expected to offer preliminary insights into short-term changes in fertility-related quality of life and neurological perception under homeopathic care. |