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CTRI Number  CTRI/2024/06/068939 [Registered on: 14/06/2024] Trial Registered Prospectively
Last Modified On: 06/04/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Single Arm Study 
Public Title of Study   To check the Efficacy and Safety of CoQ10 Capsules in patients with Oligospermia 
Scientific Title of Study   A Prospective Interventional Open label Single-centre Single arm Study to Evaluate the Efficacy and Safety of CoQ10 Capsules in Subject suffering with Oligospermia  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
009/ACRS/Co-Q/2024 V 1.0 dated 03 APR 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shubhangi Shahare  
Designation  MBBS Gynacologist and obstestrician 
Affiliation  Eras Bharti Hospital 
Address  Gastroenterology department Room no 01 Ganesham Commercial A building 4th floor nashik phata road Near govind yashada chowk sai Nagar Park pimple gurav Pimri chinchwad

Pune
MAHARASHTRA
411027
India 
Phone  9420697292  
Fax  -  
Email  dr.shubhangi.kamble@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Chandu Devanpally  
Designation  Founder & Managing Director 
Affiliation  Ardent Clinical Research Services 
Address  Clinical Research department Room No 1 Office no 302 303 level 3 nyati unitree building yerwada

Pune
MAHARASHTRA
411006
India 
Phone  9545817447  
Fax  -  
Email  cdevanpally@ardent-cro.com  
 
Details of Contact Person
Public Query  
Name  Mr Chandu Devanpally  
Designation  Founder & Managing Director 
Affiliation  Ardent Clinical Research Services 
Address  Clinical Research department Room No 1 Office no 302 303 level 3 nyati unitree building yerwada
Pune
Pune
MAHARASHTRA
411006
India 
Phone  9545817447  
Fax  -  
Email  cdevanpally@ardent-cro.com  
 
Source of Monetary or Material Support  
Ardent Clinical Research Services office no 302 303 level 3 Nyati unitree building pune nagar highway yerwada 411006 Pune INDIA 
 
Primary Sponsor  
Name  M/s Synthite Industries Private Limited 
Address  Synthite Corporate House, VIII 683-A Kadayiruppu Kolenchery Ernakulam Kerala 682 311 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shubhangi Shahare  Eras Bharti Hospital  Gatroenterology department Room No 01 Ganesham Commercial A building 4th Floor Nashik Phata Road Near Govind Yashada Chowk Sai Nagar Park Pimple Gurav Pimpri Chinchwad 411027
Pune
MAHARASHTRA 		 9420697292
-
dr.shubhangi.kamble@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sai Krupa Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N461||Oligospermia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  CoQ10 Capsules all-natural Coenzyme Q10 with SOC  Patient will be asked to consume 1 capsule twice daily after breakfast and after dinner for total of 12 weeks duration along with SOC 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Male 
Details  1 Male participants aged 18 to 50 years
2 Diagnosis of oligospermia, confirmed by semen analysis showing a sperm concentration of less than 15 million sperm per milliliter or through medical history of the subjects
3 Willingness to provide informed consent to participate in the study
4 Ability to comply with the study protocol including attending study visits and completing study-related assessments.
5 Stable sexual partner or intention to engage in heterosexual intercourse for the duration of the study
6 Willingness to refrain from using other fertility treatments or supplements during the study period
7 Adequate understanding of the study procedures and willingness to follow the investigators instructions 
 
ExclusionCriteria 
Details  1. History and drug alcohol abuse smoking
2. BMI greater than 30 kg per m2
3. History of cancer chemotherapy
4. History of significant medical conditions that could affect fertility or interfere with study participation including severe cardiovascular disease uncontrolled hypertension renal failure liver disease or malignancy
5. Contraindication for the use of CoQ10
6. Genital disease (cryptorchidism current genital inflammation or varicocele)
7. Known history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS) related illness and or known history of Hepatitis B virus (HBV) defined by presence of hepatitis B surface antigen (HBsAg) and or known history of Hepatitis C virus (HCV) defined by presence of hepatitis C antibody (HCVAb)
8. Genital trauma or surgery to the reproductive system
9. Hepatobiliary disease
10. Significant renal insufficiency
11. Occupational exposures to reproductive toxins
12. Endocrine abnormality
13. Recent or current sexually transmitted infection
14. Use of cytotoxic drugs
15. Use of immunosuppressants
16. Clinically relevant systemic disease (e g Insulin dependent diabetes adrenal dysfunction organic intracranial lesion, or hypothalamic tumor) or serious illness (Neoplasia)
17. Daunorubicin, Doxorubicin, Blood Pressure Medications Warfarin Timolol atorvastatin cerivastatin lovastatin pravastatin simvastatin gemfibrozil tricyclic antidepressant medications (including amitriptyline amoxapine clomipramine desipramine doxepin imipramine nortriptyline protriptyline and trimipramine) multivitamins or any vitamin supplementation except Folic acid
18.Use of anticonvulsants
19.Use of androgens or antiandrogens
20.History of central nervous system injury
21.Neurological or psychiatric disease to potentially compromise study data collection.
22.Abnormal COH screening blood done for both partners, including prolactin thyroid stimulating hormone prior to participation in study
23Treatment of erectile dysfunction with any drugs during the past 4 weeks
24 Current supplementation with ingredients being tested unless 1month washout period

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1 Percent change in sperm count/concentration sperm motility from  1 Screening to EOT at week 12
 
 
Secondary Outcome  
Outcome  TimePoints 
1 Change in Hormonal Levels
2 Improvement in Total IIEF-EF score
3 Improvement in score of fertility quality of life questionnaire
4 Improvement in Male Sexual Health Questionnaire (MSHQ) Score 		 1 Baseline to EOT at week 12
2 baseline to EOT at week 12
3 Baseline to EOT at week 12
4 Baseline to EOT at week 12
 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   26/06/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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 study is designed as Prospective, Interventional, Open label, Single-centre, Single arm. Participants enrolled in this prospective, interventional, open-label, single-center, single-arm study will receive the CoQ10 Capsule along with defined SoC, a formulation comprising all-natural Coenzyme Q10. The treatment regimen is designed to assess the safety and efficacy of this capsule in individuals experiencing low sperm count and quality. The treatment duration will be 3 months, with each participant taking 2 capsules a day (after breakfast and after dinner). Various parameters will be assessed including Quality of Life questionnaires, Hematology, Biochemistry, and Liver function. Adverse Events (AE) and Serious Adverse Events (SAE) will be monitored and documented throughout the study duration. 
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