Clinical study on TESTODAATÃ?Â® in male subjects during resistance training

Evaluation of Efficacy and Safety of TESTODAATÃ?Â® in Male Subjects during resistance training Ã¢â?¬â?? A Randomized, Double Blind, Placebo Controlled, multi-centre, Comparative, interventional, Prospective Study - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/07/034548

Enrollment

Registered

2021-07-02

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: TESTODAATÃ?Â® Capsule: TESTODAATÃ?Â® Contains Fenugreek seeds Extract (Trigonella foenum-graecum) Ã¢â?¬â?? 275 mg Dosage and Treatment Duration: As per computer generated randomization

Eligibility

Inclusion criteria

Inclusion criteria: 1. Moderately active (regular aerobic exercise for at least 4 hours per week), 2. Subjects with no known musculoskeletal pathology 3. Subjects willing to sign informed consent and to undergo all the study procedure.

Exclusion criteria

Exclusion criteria: 1. Subjects with no known musculoskeletal pathology 2. Subjects using systemic corticosteroids within 2 months of screening 3. Subjects with any other investigational product within 1 month prior to randomization; 4. Subjects with uncontrolled diabetes mellitus and hypertension 5. Subjects with known tuberculosis, HIV, ischemic heart disease, cancer, kidney failure 6. Subjects with significant abnormal laboratory parameters 7. Known hypersensitivity to any of the ingredients of TESTODAATÃ?Â® 8. Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his/her participation in, and completion of the protocol

Design outcomes

Primary

Measure	Time frame
Comparative change in muscle strength and endurance during resistance training (bench press and leg press) at baseline 4 week and end of 8 weeks of resistance training program between two groupsTimepoint: At baseline visit, 4 weeks and end of 8 weeks	—

Secondary

Measure	Time frame
1). Comparative change in skinfold thickness, % body fat, body weight, body mass index, lean body mass. 2). Comparative change in serum Creatinine, BUN and serum total testosterone 3) Comparative change in strength, stamina, energy, endurance 4). Comparative change in global assessment for overall change 5). Comparative assessment of tolerability of study products 6). Adverse events and safety lab parameters Timepoint: At baseline visit, 4 weeks and end of 8 weeks	—

Measure

Time frame

1). Comparative change in skinfold thickness, % body fat, body weight, body mass index, lean body mass. 2). Comparative change in serum Creatinine, BUN and serum total testosterone 3) Comparative change in strength, stamina, energy, endurance 4). Comparative change in global assessment for overall change 5). Comparative assessment of tolerability of study products 6). Adverse events and safety lab parameters Timepoint: At baseline visit, 4 weeks and end of 8 weeks

—

Countries

India

Contacts

Public ContactDr Sanjay Tamoli

Target Institute of Medical Education and Research

targetinstitute@yahoo.com9322522252

Outcome results