FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/10/075723 [Registered on: 23/10/2024] Trial Registered Prospectively
Last Modified On: 22/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effect of Ekanayaka and Haridra with buttermilk in lowering the FBS and HbA1c level in Prediabetes among adults of age group 30 to 50 years. 
Scientific Title of Study   Effect of medicated takra with Ekanayaka and Haridra in Prediabetes. 
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 Seethal Surendran K 
Designation  PG Scholar 
Affiliation  Government Ayurveda College, Tripunithura 
Address  Department of Swasthavritta Government Ayurveda College, puthiyakavu, Dhanwantari Nagar, Tripunithura

Ernakulam
KERALA
682301
India 
Phone  9895420319  
Fax    
Email  seethalsurendran1965@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jayan D 
Designation  Professor and HOD 
Affiliation  Government Ayurveda College, Tripunithura 
Address  Department of Swasthavritta Government Ayurveda College, puthiyakavu, Dhanwantari Nagar, Tripunithura

Ernakulam
KERALA
682301
India 
Phone  9447104383  
Fax    
Email  dr.jayan.d@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Jayan D 
Designation  Professor and HOD 
Affiliation  Government Ayurveda College, Tripunithura 
Address  Department of Swasthavritta Government Ayurveda College, puthiyakavu, Dhanwantari Nagar, Tripunithura

Ernakulam
KERALA
682301
India 
Phone  9447104383  
Fax    
Email  dr.jayan.d@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurveda college, Tripunithura , Ernakulam, Kerala-682301, India 
 
Primary Sponsor  
Name  Goverment Ayurveda College, Tripunithura 
Address  Department of Swasthavritta Government Ayurveda College, puthiyakavu, Dhanwantari Nagar, Tripunithura 
Type of Sponsor  Other [Government Ayurveda College] 
 
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 Seethal Surendran K  Government Ayurveda College , Tripunithura  Department of Swasthavritta Government Ayurveda College, puthiyakavu, Dhanwantari Nagar, Tripunithura
Ernakulam
KERALA 		 9895420319

seethalsurendran1965@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Committee for Ethics in Research, Government Ayurveda College Tripunithura, Ernakulam-682301  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:R730||Abnormal glucose. Ayurveda Condition: PRAMEHA-PURVARUPAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Ekanayaka and haridra takra, Reference: Chikitsamanjari Pramehachikitsa, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Takra), Additional Information: -Chikitsamanjari 19th chapter pramehachikitsa 49th sloka
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Subjects in the age group of 30 to 50 years.
2.Participants from prediabetic population (FBS between 110-125mg/dl , HbA1c between 5.7-6.4%) who are not under any medication for lowering blood glucose level
3.Subjects with written informed consent 
 
ExclusionCriteria 
Details  1.Subjects of diabetic population whose FBS level
is above 125mg/dl and HbA1c
above 6.4%
2.Pregnant ladies and lactating mothers
3.Subjects who have done any surgeries within last
6 months.
• Subjects who are under steroid medication
• Subjects coming under the contraindications of takra – wounded person, hot
climate, weak person, fainting, vertigo, burning sensation, haemorrhages 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Effect of medicated takra with Ekanayaka and Haridra in lowering the level of FBS in prediabetes.  Intake of takra will be continued for 45 days.
FBS will be assessed on the 0th ,16th, 46th and 91st day. 
 
Secondary Outcome  
Outcome  TimePoints 
Effect of medicated takra with Ekanayaka and Haridra in lowering the level
of HbA1C in prediabetes. 		 HbA1c will be assessed on 0th day and 91st day. 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
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)   05/11/2024 
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="3"
Days="1" 
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
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  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 [seethalsurendran1965@gmail.com].

  6. For how long will this data be available start date provided 10-03-2027 and end date provided 13-04-2028?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   A clinical trial with 32 subjects will be selected from the OPD consultation of Government Ayurveda College Tripunithura based on inclusion and exclusion criteria.
The subjects will be administered with medicated takra with Ekanayaka and Haridra for a period of 45 days.
FBS will be assessed on the 0th , 16th , 46th and 91st day. HbA1c will be assessed on 0th and 91st day.
Data will be collected with a detailed case performa.
The outcome of study will be assessed, processed and analyzed statistically.
 
Close