| CTRI Number |
CTRI/2021/01/030391 [Registered on: 11/01/2021] Trial Registered Prospectively |
| Last Modified On: |
08/01/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical study to evaluate the safety and efficacy of ABE-0520 on middle-aged male subjects with androgen deficiency |
|
Scientific Title of Study
|
A randomized, double-blind, placebo-controlled, clinical study to
evaluate the influence of ABE-0520 on vitality and quality of life
among healthy middle-aged male subjects characterized with androgen deficiency syndrome. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Guruprasad |
| Designation |
Principal investigator |
| Affiliation |
Divakar’s Speciality Hospital |
| Address |
Department of GYnecology,Ground Floor,#220, 9th Cross, 2nd phase, JP Nagar, Next to Nilgiris
Bangalore
KARNATAKA
560078
India |
| Phone |
9482164779 |
| Fax |
|
| Email |
drguruprasad.research@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd |
| Address |
#9,1st Floor, Mythri Legacy, Chelekere Main Road, Kalyan Nagar
Bangalore
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd |
| Address |
#9,1st Floor, Mythri Legacy, Chelekere Main Road, Kalyan Nagar
Bangalore
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Akay Natural Ingredients Pvt. Ltd,Malaidamthuruthu P.O Ernakulam Kerala, India |
|
|
Primary Sponsor
|
| Name |
Akay Natural Ingredients Pvt Ltd |
| Address |
Malaidamthuruthu P.O Ernakulam Kerala, India |
| Type of Sponsor |
Other [Manufacturer of natural plant based food ingredients and Nutraceutical ingredients] |
|
|
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 Guruprasad |
Divakar’s Speciality Hospital |
Department of Gynecology,Ground Floor,#220, 9th Cross, 2nd phase, JP Nagar, Next to Nilgiris
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
990077357
drguruprasad.research@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Divakars Speciality Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Middle aged male subjects with androgen deficiency |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ABE-0520 |
Oral administration of ABE-0520 capsules twice a day for 84 days |
| Comparator Agent |
Placebo |
Oral administration of Placebo capsules twice a day for 84 days |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Male |
| Details |
1. Subjects with morning total testosterone level less than 300 ng/dL and confirming by repeating measurement of total testosterone level.
2. At screening, subject with androgen deficiency symptoms
3.Subjects with no history of surgical or medical castration, diagnosed erectile dysfunction or any physical disability that may limit sexual function
4. Non-smoker
5. Subject understands the study procedures, is ready to comply and provide signed informed consent form (ICF) to participate in the study. |
|
| ExclusionCriteria |
| Details |
1. Subjects with history of Uncontrolled diabetes and hypertension,Diagnosable mental health disorder,Cancer, Thyroid diseases, Liver and gall bladder diseases, Renal failure, Chronic fatigue syndrome, Asthma, Cardiovascular disorders, Subjects diagnosed with prostate cancer or benign prostatic hypertrophy, had an acute genitourinary disorder or history of genital surgery.
2. Subjects who has been administered any PDE-V inhibitors (sildenafil, tadalafil, or vardenafil) and chemotherapy, corticosteroid, anticoagulation, testosterone, antiandrogen medication within the four weeks prior to enrollment and during the entire course of the study
3. Subjects undergone any treatment/ therapy for any sexual disorder during last 6 months
4. Subjects having symptoms of viral infection, including COVID-19 infection
5. Subjects with known hypersensitivity to Ashwagandha extract
6. History of smoking, alcohol/drug abuse
7. Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study.
8. History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol.
9. Any condition that in opinion of the Investigator, does not justify the subject’s participation in the study.
10. Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in hormonal levels |
Day 0, Day 42, Day 84 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in Immunity biomarker levels |
Day 0, Day 42, Day 84 |
| Changes in Questionnaire based assessments |
Day 0, Day 42, Day 84 |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
15/01/2021 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
"None Yet" |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomized (1:1), double-blind, two arm, placebo-controlled clinical
study. Middle aged male subjects meeting all inclusion criteria and no exclusion
criteria will sign a written informed consent and will be enrolled in the study.
After passing the eligibility criteria, subjects will be randomized into 2 treatment arms in a 1:1 ratio, to
receive ABE-0520 or placebo, twice a day, after breakfast and dinner, for a period of
12 weeks (84 days).The subject will arrive at the study site early morning in a fasted state and blood samples will be
collected for laboratory assessments.Post sample collection, the subjects will be administrated questionnaires to assess the androgen deficiency symptoms, stress, fatigue, sexual function, mood,Sleep and quality of life, The study is planned to be conducted in 4 visits over a period of 84 days. |