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CTRI Number  CTRI/2024/02/062518 [Registered on: 12/02/2024] Trial Registered Prospectively
Last Modified On: 20/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   An Open-Label, Single-Centre Behavioural study to Evaluate the Impact of Shilajit Supplements in increasing the Quality of Life in Men 
Scientific Title of Study   A Prospective, Single-arm, Open-Label, Single-Centre Behavioural Study to Evaluate the Impact of Shilajit Supplements in increasing Quality of Life in Men 
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 Manjunath U 
Designation  Principal Investigator 
Affiliation  Good Life Hospital 
Address  Good Life Hospital No. 55-56, Bhoo Samartha Layout, Medahalli - Kadugodi Road, Bangalore – 560049

Bangalore
KARNATAKA
560049
India 
Phone  9900282899  
Fax    
Email  udrmanjunath@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vijay Kimtata 
Designation  Medical Monitor 
Affiliation  Azuretale Private Limited 
Address  Ground Floor, K3/2,Vishnu Mandir Co.Op.Hsg.Soc., Bangur Nagar, Goregaon West, Mumbai, Mumbai City, Maharashtra, 400104

Mumbai
MAHARASHTRA
400104
India 
Phone  919816333352  
Fax    
Email  vijaykimtata.vk@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ms.Sathyavathi LM 
Designation  HOD, Clinical Operations 
Affiliation  Samahitha Research Solutions 
Address  Second Floor, #1204, ASHVA‟, 26th Main Road, 9th Block, Jayanagar, Bengaluru - 560069

Bangalore
KARNATAKA
560069
India 
Phone  9739001749  
Fax    
Email  satyalm@samahitha.com  
 
Source of Monetary or Material Support  
Azuretale Private Limited  
 
Primary Sponsor  
Name  Azuretale Inc 
Address  838 Walker Road, Suite 21-2 in the city of Dover, Kent, 19904  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Azuretale Private Limited  Ground Floor, K3/2,Vishnu Mandir Co.Op.Hsg.Soc., Bangur Nagar, Goregaon West, Mumbai, Mumbai City, Maharashtra, 400104  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Manjunath U  Good Life Hospital  No. 55-56, Bhoo Samartha Layout, Medahalli - Kadugodi Road, Bangalore – 560049
Bangalore
KARNATAKA 		 6364898825

udrmanjunath@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Pranav Diabetes Center Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Quality of Life, Cognitive Function, Sleep Pattern and Immune functions 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Shilajit Supplements, Reference: Rasa rattan smuchaya 62, Route: Oral, Dosage Form: Churna/ Powder, Dose: 400(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: No
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Male 
Details  1.Age Range: Adult males aged between 30 and 60 years.
2.Health Status: Individuals experiencing reduced vitality or cognitive issues but generally in good health.
3.Consent:Willing to provide informed consent and adhere to study protocol.
4.Availability: Able to participate in all scheduled visits and assessments during the 30- day study period.
 
 
ExclusionCriteria 
Details  1.Chronic Diseases: Individuals with severe chronic diseases, especially uncontrolled diabetes, cardiovascular diseases, or severe neurological disorders.
2.Current Medication: Use of cognitive enhancers, testosterone supplements, or other medications that might interfere with the study outcomes.
3.Substance Abuse: History of alcohol or substance abuse within the last six months.
4.Psychiatric Conditions: Significant psychiatric disorders that could affect compliance or skew results.
5.Other Clinical Trials: Participation in another clinical trial within the last three months.
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Quality of Life improvement
2.Improvement in the testosterone levels.
3.Cognitive Function enhancement. 		 Day 0, 10, 20 and 30 
 
Secondary Outcome  
Outcome  TimePoints 
1.Improvement in Sleep Patterns.
2.Assessment of General Immune functions.
3.Safety  		 Day 0, 10, 20 and 30 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   17/02/2024 
Date of Study Completion (India) 16/03/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
Days="30" 
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   This is a prospective, single-arm, open label, single centre behavioural study to evaluate the impact of Shilajit supplements in increasing quality of life in men.

Shilajit, a sticky substance found primarily in the rocks of the Himalayas, has been used in traditional medicine for centuries. It is composed of humus and organic plant material that has been compressed by layers of rock. Shilajit is rich in fulvic acid and has an array of minerals and trace elements, making it a potent supplement.Previous studies have indicated the potential of Shilajit in improving physical performance and reducing fatigue. Its impact on cognitive functions and overall well-being, however, has not been extensively researched. This study aims to fill this gap by systematically investigating the effects of Shilajit supplementation on the quality of life in men. The study will measure various parameters such as energy levels, cognitive function, and overall well- being before and after supplementation. This research could provide a natural alternative to improve the quality of life, particularly for those who prefer or require non-pharmacological interventions.

The primary objective of the study is to assess quality of life through assessment of improvement in physical vitality, hormonal balance, cognitive function enhancement and impact on sexual health. The secondary objective will focus on assessment of improvement in sleep patterns, general immune functions and safety parameters.

The study has been approved by an Registered Independent Ethics Committee.

The eligible subjects will be enrolled into the study after obtaining informed consent by the investigator. The study will include a total of 50 participants, all of whom will receive a daily dose of 400 mg Shilajit. It is a 30-day trial and is structured into four key visits: the initial recruitment and baseline assessment on Day 1, followed by three follow-up visits on Days 10, 20, and 30. During these visits, participants will undergo assessments using scales such as the WHO-5 Well-being Index and the Montreal Cognitive Assessment (MoCA), along with self-reported questionnaires for mood and stress, and basic physical fitness tests. The subjects will be monitored throughout the study for safety and at the end of the study, the data will be analysed using the statistical tests mentioned in the protocol followed by generation of the study report.








 
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