FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/09/045375 [Registered on: 09/09/2022] Trial Registered Prospectively
Last Modified On: 30/08/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   safety and anti-aging efficacy of orally administered herbal extract formulations in elderly healthy individuals 
Scientific Title of Study   A randomized, double blind, placebo controlled, comparative study to evaluate the safety and anti-aging efficacy of orally administered herbal extract formulations in elderly healthy individuals 
Trial Acronym  AAHT01 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Melvin George  
Designation  Professor 
Affiliation  SRM Medical College Hospital and Research Centre 
Address  Department of Clinical Pharmacology 3rd floor I Block SRM Medical College Hospital and Research Centre SRM Nagar Potheri Kattankulathur Chengalpattu Tamil Nadu 603203 India

Chennai
TAMIL NADU
603203
India 
Phone  9894133697  
Fax    
Email  melvingeorge2003@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Aboli Girme 
Designation  Senior Manager-Research and Innovation 
Affiliation  Pharmanza Herbal Private Limited 
Address  Pharmanza Herbal Private Limited 214, Borsad Tarapur Road, Near Vadadla Patia, Kaniya, Dharmaj, Gujarat, India - 388435

Anand
GUJARAT
388435
India 
Phone  7043534016  
Fax    
Email  ardm@pharmanzaherbals.com  
 
Details of Contact Person
Public Query  
Name  Dr Aboli Girme 
Designation  Senior Manager-Research and Innovation 
Affiliation  Pharmanza Herbal Private Limited 
Address  Pharmanza Herbal Private Limited 214, Borsad Tarapur Road, Near Vadadla Patia, Kaniya, Dharmaj, Gujarat, India - 388435

Anand
GUJARAT
388435
India 
Phone  7043534016  
Fax    
Email  ardm@pharmanzaherbals.com  
 
Source of Monetary or Material Support  
Pharmanza Herbal 
 
Primary Sponsor  
Name  Pharmanza Herbal 
Address  Pharmanza Herbal Private Limited 214 Borsad Tarapur Road Near Vadadla Patia Kaniya Dharmaj Gujarat India 388435 ​  
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 
Melvin George  SRM Medical College Hospital & Research Centre  Room no 1 Block I Dept of Clinical Pharmacology
Kancheepuram
TAMIL NADU 		 9894133697

melvingeorge2003@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRM Instiutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Aging 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Ashwagandha, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 24 Weeks, anupAna/sahapAna: Yes(details: water), Additional Information: -
(2) Medicine Name: Nishamalaki, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 24 Weeks, anupAna/sahapAna: Yes(details: water), Additional Information: -
2Comparator Arm (Non Ayurveda)-PlaceboMaltodextrin - Route: Oral; Dosage form: capsule, Dose:500 (mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration:24 weeks
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Patients above 60 years of age belonging to either gender (males/females)
2. Fasting plasma glucose < 126 mg/dl, 2-hr glucose between 140 - 199 mg/dl
3. Patients willing to follow all trial procedures.
 
 
ExclusionCriteria 
Details  Patients suffering from systemic illness necessitating long term drug treatment rheumatoid arthritis psychoneuroendocrinal disorders
Patients having any cardiovascular disease
Patients with diabetes mellitus HbA1c >6.5 FBS >126 mg/dl and PPBS > 200 mgdl
Patients with the concurrent hepatic disorder (defined as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >2 times upper normal limit, total bilirubin alkaline phosphates (ALP) >2 times the upper normal limit
Renal disorder is defined as S Creatinine > 3 mgdl
Patients with pulmonary dysfunction bronchial asthma and chronic obstructive pulmonary disease COPD
Inflammatory bowel disease
Severe dementia
Severe infection
Non-ambulatory patients or any other condition that may jeopardize the study
Subjects who are currently alcoholics and/or use psychoactive substances patients who have completed participation in any other clinical trial during the past 6 months
Subjects who have a history of allergy hypersensitivity or intolerance to investigational product
Subjects who have a history or evidence of active infection or febrile illness within 7 days prior to the screening assessment and subjects who have a history of any other clinically significant disease or disorder that, in the opinion of the principal investigator, may place the subject at risk due to participation in the study, or may influence the results of the study or the subject ability to complete the study 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
3 minute walk test
hand grip strength test
MMSE
Telomere length, cellular senescence -PBMC
Sirt 1, Sirt 6, NAD+ and DNA methylation assay 		 0, 12 and 24 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
safety testing LFT RFT  0 and 24 weeks 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
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   Phase 2 
Date of First Enrollment (India)   15/09/2022 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response (Others) -  Summary of results

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [melvingeorge2003@gmail.com].

  6. For how long will this data be available start date provided 11-07-2024 and end date provided 11-07-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is an attempt to test the anti-aging property of  Ashwagandha, Nishamalaki by testing the changes in physical activity using walking speed and hand grip, telomere length and cell senescence in peripheral blood mononuclear cells, aging biomarkers including Sirt 1, Sirt 6, NAD+ and DNA methylation, blood glucose levels and insulin resistance and the safety of these herbal formulations by assessing vital signs and biochemical investigations (hematology, lipid profile, liver function test)  groups. the changes in these parameters will be compared between 0 and 24 weeks and the difference between the herbal formulations and that seen in placebo group will be compared to derive the anti aging property of these herbal compounds.   
Close