| CTRI Number |
CTRI/2026/02/103686 [Registered on: 12/02/2026] Trial Registered Prospectively |
| Last Modified On: |
11/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
To study the effect of homoeopathic treatment in men with sexual weakness |
|
Scientific Title of Study
|
Constitutional approach in the homoeopathic management of male sexual weakness-quasi experimental 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 Tanmay Chandrakant Lingayat |
| Designation |
PG Scholar |
| Affiliation |
Sonajirao Kshirsagar Homoeopathic Medical College, Beed |
| Address |
Department of Organon and Homoeopathic Philosophy, Division Homoeopathy, Room no 3, Sonajirao Kshirsagar Homoeopathic Medical College, Beed, Maharashtra
Bid
MAHARASHTRA
431122
India |
| Phone |
9763691945 |
| Fax |
|
| Email |
tanmayligayat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Prabhakar Kulkarni |
| Designation |
Associate Professor and Guide |
| Affiliation |
Sonajirao Kshirsagar Homoeopathic Medical College, Beed |
| Address |
Department of Organon and Homoeopathic Philosophy, Division Homoeopathy, Room no 3, Sonajirao Kshirsagar Homoeopathic Medical College, Beed, Maharashtra
Bid
MAHARASHTRA
431122
India |
| Phone |
9423296405 |
| Fax |
|
| Email |
drrajeshkulkarni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tanmay Chandrakant Lingayat |
| Designation |
PG Scholar |
| Affiliation |
Sonajirao Kshirsagar Homoeopathic Medical College, Beed |
| Address |
Department of Organon and Homoeopathic Philosophy, Division Homoeopathy, Room no 3, Sonajirao Kshirsagar Homoeopathic Medical College, Beed, Maharashtra
Bid
MAHARASHTRA
431122
India |
| Phone |
9763691945 |
| Fax |
|
| Email |
tanmayligayat@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sonajirao Ksirsagar Homoeopathic Medical College, Vidyanagar West, Beed 431122 |
|
|
Primary Sponsor
|
| Name |
Dr Tanmay Chandrakant Lingayat |
| Address |
Sonajirao Ksirsagar Homoeopathic Medical College, Vidyanagar West, Beed 431122 |
| Type of Sponsor |
Other [Self Sponsored] |
|
|
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 Tanmay Chandrakant Lingayat |
Sonajirao Kshirsagar Homoeopathic Medical College & Hospital |
Department of Organon and Homoeopathic Philosophy, Division Homoeopathy, Room no 3, Sonajirao Kshirsagar Homoeopathic Medical College, Beed, Maharashtra
Bid
MAHARASHTRA |
9763691945
tanmayligayat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sonajirao Kshirsagar Homoeopathic Medical College, Beed |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N538||Other male sexual dysfunction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Management |
Individualized homoeopathic medicines prescribed based on detailed case taking. Medicines will be selected according to the totality of symptoms and administered in appropriate potency and dosage as per homoeopathic principles |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
Cases presenting with various and characteristic symptoms,modalities in adult age group and male’s will be included in my study
Subject between 21 years to 45 years of age were included in the study
Patient who are enough Mentally stable and Physically capable of participating in treatment and assessment procedure. |
|
| ExclusionCriteria |
| Details |
1.Patient having advance and irreversible
pathological conditions
2.Ruling out other medical conditions that
might be causing similar symptoms.
3.Substance abuse.
4.Inability to give informed consent
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.INTERNATIONAL INDEX OF ERECTILE FUNCTION
2.-PREMATURE EJACULATION DIAGNOSTIC TOOL(PEDT)
QUESTIONNAIRE
3.SEXUAL HEALTH INVENTORY FOR MEN(SHIM)- LOW LIBIDO |
Outcome Assessment Will Be Done Only At Pre Study (Baseline) And Post Study At End Of 3 Months. Follow Up Visits Will Be Coducted evey Month Durind This Period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
24/02/2026 |
| 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
|
This study aims to study the effectiveness of constitutional homeopathic treatment in improving symptoms of male sexual weakness in a quasi-experimental study design. The study will be conducted on 44 patients, Participants will receive individualized homoeopathic treatment based on detailed case evaluation. Male sexual weakness severity will be assessed using the 1- INTERNATIONAL INDEX OF ERECTILE FUNCTION(IIEF) 2-PREMATURE EJACULATION DIAGNOSTIC TOOL(PEDT)
QUESTIONNAIRE 3-SEXUAL HEALTH INVENTORY FOR MEN(SHIM)- LOW LIBIDO scales before and after treatment. The study duration is 18 months, and outcomes will be measured by change in 1- INTERNATIONAL INDEX OF ERECTILE FUNCTION(IIEF) 2-PREMATURE EJACULATION DIAGNOSTIC TOOL(PEDT) QUESTIONNAIRE 3-SEXUAL HEALTH INVENTORY FOR MEN(SHIM)- LOW LIBIDO , After Data Collection ,Data Will Be Analysed And Evaluated With Appropriate Statastical Test. |