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CTRI Number  CTRI/2025/07/090919 [Registered on: 15/07/2025] Trial Registered Prospectively
Last Modified On: 12/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study to evaluate the effect of TruBlk™ Shilajit Resin on improving sexual health in males  
Scientific Title of Study   A randomized, double-blind, multicenter, placebo-controlled clinical study to evaluate the safety and efficacy of TruBlk™ Shilajit Resin in improving sexual health in males.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
ARL/CT/020/25 Version: 1.0 Date: 25-Jun-2025   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Utsa Basu 
Designation  Principal Investigator 
Affiliation  Dr. Utsa Basus Clinic 
Address  Dr. Utsa Basus Clinic, 65A Middle Road, Philips More, Entally, Pin 700014, Kolkata

Kolkata
WEST BENGAL
700014
India 
Phone  9432658968  
Fax    
Email  dr.utsabasu@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Divya Yadav 
Designation  Founder 
Affiliation  Amaara Ayurveda 
Address  Amaara Ayurveda Plot No. 63 and 64, Sector 6, IMT Manesar, Gurugram, Haryana 122050, India

Gurgaon
HARYANA
122050
India 
Phone  9560891900  
Fax    
Email  divya.yadav@amaarabotanicals.com  
 
Details of Contact Person
Public Query  
Name  Mr Manoj Karwa 
Designation  Head Clinical Trial & Pharmacovigilance 
Affiliation  Auriga Research Private Limited 
Address  Auriga Research Private Limited Plot No. 136, Sector 5, IMT Manesar, Gurugram, Haryana 122050, India

Gurgaon
HARYANA
122050
India 
Phone  9313367656  
Fax    
Email  manojkarwa@aurigaresearch.com  
 
Source of Monetary or Material Support  
Amaara Ayurveda, Plot No. 63 & 64, Sector-6, IMT Manesar, Gurugram, Haryana – 122050, India  
 
Primary Sponsor  
Name  Amaara Ayurveda 
Address  Plot No. 63 & 64, Sector-6, IMT Manesar, Gurugram, Haryana – 122050, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Utsa Basu  Dr. Utsa Basus Clinic   Room no 03, Ground Floor, 65A Middle Road, Philips More, Entally, 700014, Kolkata Kolkata WEST BENGAL
Kolkata
WEST BENGAL 		 9432658968

dr.utsabasu@yahoo.com 
Dr Nirupam Adlakha  Guru Angad Dev Medical Centre  Ground Floor OPD, Gurudwara Road, Tilak Nagar, New Delhi - 110018
West
DELHI 		 9810868186

drnirupamadlakha@gmail.com 
Dr Nirupam Adlakha  Mata Chanan Devi Hospital   Room No. 713, Urology OPD, C 1, Janakpuri, New Delhi 110058 West DELHI
South West
DELHI 		 9810868186

drnirupamadlakha@gmail.com 
Dr Kurmi Prakash Harishchandra  Shivam Hospital  Ground Floor, OPD Area, C 4, Satyanarayan Society, Gor no Kuvo, Jasodanagar Char Rasta, Maninagar, Ahmedabad 380058, Gujrat Ahmadabad GUJARAT
Ahmadabad
GUJARAT 		 9825047692

dr_prakashkurmi@yahoo.co.in  
Dr Rajesh Chhabra  Shri Krishna Super Speciality Institute of Ayurveda  Room No. 02, OPD Area, Ground Floor, 48A, Block C4A, Janakpuri, New Delhi, Delhi, 110058
South West
DELHI 		 9810584090

drrajchh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
GSER Independent Ethics Committee  Approved 
GSER Independent Ethics Committee  Approved 
Independent Ethics Committee, Avinash Institute of Craniofacial and Reconstructive Surgery AICRS   Approved 
Mahavir Hospital Ethics Committee Mahavir hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E291||Testicular hypofunction. Ayurveda Condition: OJAKSHAYAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: TruBlk™ Shilajit Resin, Reference: NA, Route: Oral, Dosage Form: Arka, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Warm Water), Additional Information: with 100 to 250 mL of warm water once in the morning and once in the evening.
2Comparator Arm (Non Ayurveda)-Placebo250 mg placebo Resin twice daily with one 100-250 mL of warm water once in the morning and once in the evening.
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  55.00 Year(s)
Gender  Male 
Details  1. Male participants aged 35 to 55 years with BMI less than or equal to 30 kg per m2.
2. Participants who have scored 11 to 25 on the Erectile Function (EF) domain of the International Index of Erectile Function (IIEF) at screening visit.
3. Participants with positive Saint Louis University Androgen Deficiency in Aging Males (ADAM) questionnaire indicative of testosterone deficiency at screening visit.
4. Participants should be in an active stable sexual relationship (only married participants) for the entire duration of the study.
5. Participants willing to participate in clinical study and who have read understood and signed the informed consent form.
 
 
ExclusionCriteria 
Details  1. Previous events or other severe conditions that may affect sexual health or metabolic health.

2. Participants with genital anatomical deformities, including but not limited to penile deformities.

3. Participants for whom sexual activity is inadvisable because of their underlying disease status.

4. Female partners experiencing sexual dysfunction, such as painful intercourse, low libido, or other forms of sexual dysfunction, as well as pregnant individuals.

5. Participants with any significant comorbid condition or currently undergoing pharmacological treatment, which in the investigators judgment may interfere with the clinical study outcomes.

6. Participants that have undergone radical prostatectomy, spinal cord injury, or any other surgery of urogenital organs.

7. Participants with a history or presence of significant alcoholism or drug abuse within the past 1 year.

8. Participants with a history or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco or nicotine products more than 10 times per day.

9. Any concomitant treatment that is not permissible including but not limited to nitrates, anti androgens, chemotherapy agents, radiotherapy, etc.

10. Recent participation in another clinical study or receiving some other drug during the study besides that in the protocol.

11. Known hypersensitivity to any of the ingredients of the investigational product.

12. Participant’s concurrent use of sildenafil or other such drugs in the PDE5 inhibitor family, energy supplements, herbal or pharmaceutical aphrodisiacs, body composition enhancing agents, or other concurrent medication such as beta blockers, contraceptives, and psychotropic medications, nutraceuticals, or ayurvedic supplement for sexual health and well being.

13. Participants consuming any nutraceutical, herbal, or ayurvedic supplements for any other condition.

14. Any other clinical condition in the investigators judgment finds the study participation unsuitable for the participant.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
i. Change in total testosterone, free testosterone and cortisol levels (Baseline and Day 90)
ii. Change in IIEF score (Erectile function, orgasmic function, sexual desire, satisfaction with intercourse, overall satisfaction) at Screening, Day 30, Day 60 and Day 90
iii. Change in Hypogonadism Impact of Symptoms Questionnaire (HIS Q) a validated patient reported outcome tool designed to assess symptom severity and impact on quality of life domains at Baseline, Day 30, Day 60 and Day 90.
 		 i. Baseline and Day 90
ii. Screening, Day 30, Day 60 and Day 90
iii. Baseline, Day 30, Day 60 and Day 90. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Changes in severity & impact of fatigue on daily functioning through Fatigue Severity Score (FSS) at Baseline, day 30, day 60 & day 90.
2. Changes in the participant & investigator global assessment score at Baseline & Day 90.
3. Exploratory Endpoints: Semen Analysis & Serum Nitric Oxide at Baseline & Day 90. 		 1. Baseline, day 30, day 60 & day 90
2. Baseline & Day 90
3. Baseline & Day 90 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   28/07/2025 
Date of Study Completion (India) 06/01/2026 
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)   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  

This is a randomized, double-blind, multicenter, placebo-controlled clinical study designed to evaluate the safety and efficacy of TruBlk™ Shilajit Resin in improving sexual health in males. A total of 100 male participants aged 35 to 55 years, with a BMI less than or equal to 30 and mild to moderate erectile dysfunction, will be enrolled. Participants will be randomized in a 1:1 ratio into two groups: one receiving 250 mg of TruBlk™ Shilajit Resin twice daily, and the other receiving a matching placebo for 90 days.

The primary objective is to assess changes in total testosterone, free testosterone, cortisol, nitric oxide levels, libido, and sexual stamina. Secondary objectives include evaluating the effects on energy, mood, stress, fatigue, and overall well-being, along with safety assessments. Efficacy assessments will be conducted using standardized tools like the International Index of Erectile Function (IIEF) and the Hypogonadism Impact of Symptoms Questionnaire (HIS-Q). Fatigue will be assessed using the Fatigue Severity Scale (FSS), and an exploratory semen analysis will be conducted.

Safety will be monitored through adverse event reporting, vital signs, treatment compliance, and tolerability at scheduled visits. The study follows ICH-GCP guidelines to ensure the safety and integrity of participants and data.

 
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