| CTRI Number |
CTRI/2025/07/090761 [Registered on: 11/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Are homoeopathic medicines effective in reducing pus cells and increasing sperm count and motility |
|
Scientific Title of Study
|
A prospective study on the effect of homoeopathic medicines in pyospermia and changes in sperm count and motility |
| 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 Rabeeha K |
| Designation |
Post graduate scholar |
| Affiliation |
Government homoeopathic medical college , Karaparamba |
| Address |
Department of practice Of medicine
Government homoeopathic medical college , Karaparamba , Kozhikode
Department of Practice Of Medicine
Government homoeopathic medical college , Karaparamba , Kozhikode
Malappuram
KERALA
673010
India |
| Phone |
9447799625 |
| Fax |
|
| Email |
rabeeha33@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ABDUL HAMED |
| Designation |
Professor retired |
| Affiliation |
Kerala university of health science |
| Address |
Professor retired
Department of practice of medicine
government homoeopathic medical college , karaparamba, Kozhikkode
Department of practice of medicine
government homoeopathic medical college , karaparamba, Kozhikode
Kozhikode
KERALA
673010
India |
| Phone |
9447632227 |
| Fax |
|
| Email |
hameeddr@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rabeeha K |
| Designation |
Post graduate student |
| Affiliation |
Kerala university of health science |
| Address |
Department of practice of medicine
government homoeopathic medical college , karaparamba, Kozhikkod
Government Homoeopathic Medical College , Karaparamba Kozhikode
Kozhikode
KERALA
673010
India |
| Phone |
09447799625 |
| Fax |
|
| Email |
rabeeha33@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government homoeopathic medical college , Kozhikkode.
673010 |
|
|
Primary Sponsor
|
| Name |
Dr Rabeeha |
| Address |
Government homoeopathic medical college
Karaparmba
673010,Kerala
|
| Type of Sponsor |
Other [Self] |
|
|
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 Rabeeha K |
Government Homoeopathic Medical College , Kozhikkode |
Infertility op
third floor
room no 6
Government homoeopathic medical college , Kozhikkode
673010
Kozhikode
KERALA |
9447799625
rabeeha33@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethical Committee Government Homoeopathic Medical college Kozhikkode Kerala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N469||Male infertility, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Medicine |
Homoeopathic medicine in 30,200,1M potency will be given in an interval of 4 weeks upto 6 months and result will be analysed finally |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
Males with asthenozoospermiaa
Males with leucocyte count more than 1 million per ml of semen sample
Male with sperm count less than 15 million per ml
|
|
| ExclusionCriteria |
| Details |
Patients taking other treatments for infertilty
Patients with aspermia
Patients under antibiotic and steroid medication
Patient who had chemotherapy and radiotherapy six months prior to study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of leucocyte count |
Leucocyte count baseline value - leucocyte count final value after 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement of sperm count & sperm motility |
Sperm count & sperm motility will be measured in an interval of 6 months |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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 3 |
|
Date of First Enrollment (India)
|
20/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/07/2025 |
| 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)
|
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
|
The aim of the study is to assess the changes in sperm count and motility in patients with pyospermia and the effectiveness of homoeopathic medicines in managing such cases.33 cases will be selected according to inclusion and exclusion criteria and proper homoeopathic medicines will be administered according to homoeopathic principles. leucocytes , sperm count and sperm motility will be measured in 6 months intervals before and after study and otcome will be measured in all cases |