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CTRI Number  CTRI/2024/04/065273 [Registered on: 05/04/2024] Trial Registered Prospectively
Last Modified On: 27/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Assessment of Pharmacokinetic Interactions and Therapeutic Effect of Chandraprabha vati with Glimepiride 
Scientific Title of Study   Assessment of Metabolism mediated Pharmacokinetic Interactions and Therapeutic Potential of Chandraprabha vati with Glimepiride 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ahalya S P 
Designation  Research scholar 
Affiliation  SRM College of Pharmacy,SRMIST 
Address  Department of Pharmacy Practice SRM College of Pharmacy SRMIST Kattankulathur

Kancheepuram
TAMIL NADU
603203
India 
Phone  8056125149  
Fax    
Email  ahalyasp1994@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr T M Vijayakumar 
Designation  Professor 
Affiliation  SRM College of Pharmacy,SRMIST 
Address  Department of Pharmacy Practice SRM College of Pharmacy SRMIST Kattankulathur

Kancheepuram
TAMIL NADU
603203
India 
Phone  9003400350  
Fax    
Email  vijayakm2@srmist.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr T M Vijayakumar 
Designation  Professor 
Affiliation  SRM College of Pharmacy,SRMIST 
Address  Department of Pharmacy Practice SRM College of Pharmacy SRMIST Kattankulathur

Kancheepuram
TAMIL NADU
603203
India 
Phone  9003400350  
Fax    
Email  vijayakm2@srmist.edu.in  
 
Source of Monetary or Material Support  
SRM college of Pharmacy SRM Institute of Science and Technology 
 
Primary Sponsor  
Name  SRM College of Pharmacy SRM Institute of Science and Technology 
Address  Department of Pharmacy Practice SRM College of Pharmacy SRM Institute of Science and Technology Kattankulathur 603203 
Type of Sponsor  Research institution and hospital 
 
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 
Dr T M Vijayakumar  SRM Medical College Hospital and Research Centre,  Department of Pharmacy Practice 4th Floor SRM Medical College Hospital and Research Centre SRMIST Kattankulathur 603203
Chennai
TAMIL NADU 		 9003400350

vijayakm2@srmist.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRM Medical College Hospital and Research Centre Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  HEALTHY ADULT 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Glimepiride1 milligram of Glimepiride Once a Day Oral Route 6 Months Duration
2Intervention ArmDrugClassical(1) Medicine Name: Chandraprabha, Reference: Bhaisajya Ratnavali-Prameha Shikitcha, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 6 Months, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Male 
Details  1 Willing to give informed written consent and comply with the study requirements
2 Subject should be able to communicate effectively
3 Non smokers or individuals who smoke less than 5 cigarettes per day
4 Teetotalers or individuals who drink less than 60 ml of high alcohol content liquor or 120 ml of low-alcohol content liquor
5 Body Mass Index between 19 to 25
6 Healthy individuals as evaluated by personal history medical history and general clinical examination
7 BP should be within the range of 100 to 139 systolic and 60 to 89 diastolic Pulse rate should be within the range of 60 to 100 beats per minute Temperature between 97.8 and 99.0 degree Respiratory rate should be within the range of 14 to 18 breaths per minute
8 Normal biochemical hematological and urinary parameters
9 Normal Chest X ray
10 Negative for sexually transmitted diseases Hepatitis B Hepatitis C and Syphilis tests
11 Negative urine test for drugs of abuse for morphine barbiturates benzodiazepines amphetamine cocaine to be performed on the day of check in
12 Negative alcohol breathe analysis to be performed on the day of check in
 
 
ExclusionCriteria 
Details  1 Subjects incapable of understanding the informed consent
2 History of any major surgical procedure in the past 3 months
3 History of diabetes mellitus tuberculosis and systemic hypertension
4 History suggestive of cardiac gastrointestinal respiratory hepatic renal endocrine neurological metabolic psychiatric or haematological systems judged to be clinically significant
5 History of dysphagia
6 History of any medical disorder that is of significance in the investigators opinion
7 Present or past history of drug abuse
8 History of hypersensitivity to study formulation
9 History of allergy to vegetables and or food substances and or any other manifestations suggestive of hypersensitivity reactions
10 Present or past history of intake of drugs which potentially modify kinetics or dynamics of study medication or any other medication judged to be clinically significant by the investigator
11 Consumption of grapefruit or its products within 48 hours prior to the start of the study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
1 To determine the effect of multiple oral doses of Chandraprabha vati on the single dose Glimepiride administered in healthy adult volunteers
2 Area under the curve
3 Total body clearance
4 Volume of distribution at steady state
5 Terminal half life
6 Extent of absolute oral bioavailability
7 Peak plasma concentration
8 Time taken to reach Peak plasma concentration
 		 Baseline
Third Month
Sixth Month 
 
Secondary Outcome  
Outcome  TimePoints 
to measure adverse drug reactions during the study period  Baseline
Third Month
Sixth Month 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   13/05/2024 
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   N/A 
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 - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ahalyasp1994@gmail.com].

  6. For how long will this data be available start date provided 01-01-2025 and end date provided 01-01-2029?
    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  
1 The most Human drug interaction studies so far have examined PK interactions and have been limited to very few conventional drugs and herbal drugs. This study focuses on PK interactions and Therapeutic potential of Herbal drug with Conventional drug.
2 There has been a drastic increase in herb-drug interactions day-by-day as a result of an increase in the population using herb and its supplements along with the conventional medicines. WHO estimates that 80% world populations use herbal medicines for some aspects for primary health care .
3 More than 60% Asians resort to herbal products to treat a variety of chronic disorders such as metabolic disorder, anxiety, depression, dementia and memory impairment, headache, weight loss, PCOD etc. About one in three concurrent users was at risk of a potential herb–drug or supplement–drug interaction.
 
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