| CTRI Number |
CTRI/2024/08/072891 [Registered on: 22/08/2024] Trial Registered Prospectively |
| Last Modified On: |
21/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness homoeopathic medicines in increasing sperm count |
|
Scientific Title of Study
|
Effectiveness of Homoeopathic constitutional medicines in increasing sperm count in patients with oligospermia- A 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 Maya U S |
| Designation |
Post graduate scholar |
| Affiliation |
Government Homoeopathic medical college Kozhikode |
| Address |
Department of Organon of medicine Government Homoeopathic Medical College Karaparamba Kozhikode
Kozhikode
KERALA
673010
India |
| Phone |
8547993545 |
| Fax |
|
| Email |
drmayasivasankaran@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Babu K Thomas |
| Designation |
Former professor of Organon of Medicine |
| Affiliation |
Government Homoeopathic medical college Kozhikode |
| Address |
Op no 4
Department of organon of medicine
Government homoeopathic medical college Karaparamba Kozhikode
Kerala
673010
Kozhikode
KERALA
673010
India |
| Phone |
9400571035 |
| Fax |
|
| Email |
nbk251@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Maya U S |
| Designation |
Post graduate scholar |
| Affiliation |
Government homoeopathic medical college Kozhikode |
| Address |
Department of Organon of medicine government homoeopathic medical college Karaparamba Kozhikode
Kozhikode
KERALA
673010
India |
| Phone |
8547993545 |
| Fax |
|
| Email |
drmayasivasankaran@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Homoeopathic Medical College Kozhikode Kerala
673010 |
|
|
Primary Sponsor
|
| Name |
Dr Maya U S |
| Address |
Post graduate scholar Department of Organon of Medicine Government Homoeopathic medical college Kozhikode
Kerala
673010
|
| 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 Maya U S |
Government Homoeopathic Medical College |
Infertility and research Center in homoeopathy(IMCRH)OP no 12,under department of obstetrics and gynaecology, third floor
Government homoeopathic medical college Kozhikode
Kerala
673010
Kozhikode
KERALA |
8547993545
drmayasivasankaran@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee government homoeopathic medical college Kozhikode Kerala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N461||Oligospermia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic constitutional medicines |
The remedy will be selected according to the principles and practices of homoeopathy, and given on the basis of constitutional totality.
1 dose of constitutional medicine is dispensed in saccharum lactis, potency is selected according to susceptibility of the patient, patient is advised to take medicine orally. Duration of such treatment is 4weeks. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
1. Male patients in the age group of 21-50 years
2. People belonging to all socio-economic groups
3. Sperm count at or below 15 million/millilitre |
|
| ExclusionCriteria |
| Details |
1. Patients taking allopathic and other treatments for infertility
2. patients under immunosuppressive medications
3. Patients with azoospermia and aspermia
4. Patients with genetic defects like Klinefelter’s syndrome and congenital abnormalities
5. Patients with diseases like accessory sex gland infection, and sexually transmitted diseases
6. Patients with obstructive oligospermia
7. Cases of retrograde ejaculation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the increase in sperm, count after treatment with constitutional homoeopathic medicines in patients with oligospermia |
Each case will be reviewed in 4 weeks’ time and followed for a period of 6 months.
To assess the progression of treatment, semen analysis will be repeated every 10 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
02/09/2024 |
| 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)
|
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
|
It is a Quasi experimental study to understand the effectiveness of Homoeopathic constitutional medicines in increasing sperm count in patients with oligospermia At least two semen samples obtained more than two weeks apart will be examined to confirm the diagnosis of oligospermia Each case will be reviewed in 4 weeks’ time and followed for a period of 6 months. To assess the progression of treatment, semen analysis will be repeated every 10 weeks.
|