| CTRI Number |
CTRI/2023/09/057380 [Registered on: 11/09/2023] Trial Registered Prospectively |
| Last Modified On: |
08/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To evaluate the role of individualised Homoeopathic medicines and Tribulus terrestris Q in the improvement of quantity and quality of sperm parameters |
|
Scientific Title of Study
|
A Comparative clinical study to evaluate the Role of Individualized Homoeopathic remedy with Tribulus terrestris Q in the management of Oligoasthenoteratozoospermia |
| 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 S Sandhya |
| Designation |
PhD Scholar |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College and Hospital |
| Address |
No 10 Balaji Nagar
First Street
Virugambakkam
Chennai
Department of Practice of Medicine
Parul University, P.O.Limda, Ta.Waghodia,, Dist. Vadodara, Vadodara, Gujarat 391760
Chennai
TAMIL NADU
600092
India |
| Phone |
9841002329 |
| Fax |
|
| Email |
drsandhyakalidas@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.KIRTIDA DESAI |
| Designation |
Professor and Head, PG and PhD cordinator |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine
Parul University, P.O.Limda, Ta.Waghodia,, Dist. Vadodara, Vadodara, Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9574424363 |
| Fax |
|
| Email |
kirtida.desai@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Sandhya |
| Designation |
PhD Scholar |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College and Hospital |
| Address |
No 10 Balaji Nagar
First Street
Virugambakkam
Chennai
Deaprtment of Practice of Medicine
Parul University, P.O.Limda, Ta.Waghodia,, Dist. Vadodara, Vadodara, Gujarat 391760
Chennai
TAMIL NADU
600092
India |
| Phone |
9841002329 |
| Fax |
|
| Email |
drsandhyakalidas@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Dr Koppikars Foundation for Homoeopathy, nfertility Unit 58 Venkatnarayana Road T Nagar Chennai
Chennai, TAMIL NADU |
| Venkateswara Homoeopathic Medical College and Hospital, Infertility Unit, 4 11 Samayapuram Main Road Karambakkam Porur Chennai Chennai TAMIL NADU |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Homoeopathic medical College and Hospital |
| Address |
Po Limda Ta Waghodia Dist Vadodara 391760 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S Sandhya |
Dr Koppikars Foundation for Homoeopathy |
Infertility Unit
58 Venkatnarayana Road
T Nagar
Chennai
Chennai
TAMIL NADU |
9841002329
drsandhyakalidas@yahoo.in |
| Dr S Sandhya |
Venkateswara Homoeopathic Medical College and Hospital |
Infertility Unit,
4 11 Samayapuram Main Road
Karambakkam
Porur Chennai
Chennai
TAMIL NADU |
9841002329
drsandhyakalidas@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Dr Koppikars Foundation for Homoeopathy |
No Objection Certificate |
| Jawaharlal Nehru Homoeopathic medical College and Hospital Institutional Ethics Committee for Human Research |
Approved |
| Venkateswara Homoeopathic Medical College and Hospital |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N461||Oligospermia, (2) ICD-10 Condition: N468||Other male infertility, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic remedy |
According to each case and as per the principles of homoeopathic posology, the and frequency of repetition will be prescribed accordingly for a period of 3 months |
| Comparator Agent |
Tribulus Terrestris Q |
15 drops twice daily, after food for a period of 03 months |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
Male patients with chief complaint of infertility with sperm count less than 15 million/ml
Sperm motility less than 40 % ,
Sperm morphology less than 14 % ( WHO – reference value )
Semen volume less than 1.5 ml, – Sperm concentration less than 15 mol/ml, (As per WHO guidelines)
Oligospermia is often associated with poor motility and poor morphology. Patients with only oligospermia are also included in the study |
|
| ExclusionCriteria |
| Details |
Sperm count > 15 million/ml
Azoopermia and aspermia
Genetic abnormalities.
Any Drug abuse/addictions
Sexually Transmitted Diseases
Patients with any malignant conditions
Other anatomical abnormalities due to trauma.
Patients under medications with other system of medicine |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the improvement in sperm count at third month from baseline. |
Baseline & third month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the improvement in sperm motility & sperm morphology at third month from baseline |
Baseline & third month |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
16/09/2023 |
| 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="0"
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
|
OBJECTIVES: To study and assess the effectiveness of individualised homoeopathic remedy and Tribulus terrestris Q in the treatment of Oligoasthenoteratozoospermia. To compare the effectiveness of Individualised homoeopathic remedy with Tribulus terrestris Q.
Primary Outcome: To evaluate the improvement in sperm count at third month from baseline. Secondary Outcome: To evaluate the improvement in sperm motility and sperm morphology at third month from baseline. |