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CTRI Number  CTRI/2023/02/049894 [Registered on: 20/02/2023] Trial Registered Prospectively
Last Modified On: 18/02/2023
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Efficacy of Micon Gold Capsule in Diabetes 
Scientific Title of Study   Post-marketing open-label observational clinical study to determine the efficacy of Micon Gold Capsule in Type 2 Diabetes Mellitus 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashok Kumar Jain 
Designation  Consultant 
Affiliation  RB Diagnostic Pvt Ltd  
Address  RB Diagnostic Pvt Ltd CD 85 Block CD Salt Lake City Sector 1 Kolkata – 700064
RB Diagnostic Pvt Ltd CD 85 Block CD Salt Lake City Sector 1 Kolkata-700064
Kolkata
WEST BENGAL
700064
India 
Phone  7044517791  
Fax    
Email  dr.jainak00@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Parikshit Debnath 
Designation  Research Manager 
Affiliation  Med Pharma CRO 
Address  MED PHARMA CRO Research Division 119 Rajdanga Gold Park

Kolkata
WEST BENGAL
700107
India 
Phone  9836675720  
Fax    
Email  docdebnath84@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Parikshit Debnath 
Designation  Research Manager 
Affiliation  Med Pharma CRO 
Address  MED PHARMA CRO Research Division 119 Rajdanga Gold Park

Kolkata
WEST BENGAL
700107
India 
Phone  9836675720  
Fax    
Email  docdebnath84@gmail.com  
 
Source of Monetary or Material Support  
Jamna Herbal Research Limited E-5, New Industrial Area, Mandideep, MP - 462046  
 
Primary Sponsor  
Name  Med Pharma CRO 
Address  119 Rajdanga Gold Park Kolkata -700107 
Type of Sponsor  Contract research organization 
 
Details of Secondary Sponsor  
Name  Address 
Jamna Herbal Research Limited  E-5, New Industrial Area, Mandideep, MP - 462046  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr A K Jain  RB Diagnostic Pvt Ltd  CD 85, Block CD, Salt Lake City Sector 1, Kolkata – 700064
Kolkata
WEST BENGAL 		 7044517791

dr.jainak00@gmail.com 
Dr Parikshit Debnath  The Ayurveda Clinic and Research Centre  119, Rajdanga Gold Park, Kolkata - 700107
Kolkata
WEST BENGAL 		 9836675720

docdebnath84@gmil.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Independent Ethics Committee (Clinical Research) India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: MICON GOLD CAPSULE, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 900(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: LUKE WARM WATER), Additional Information:
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Patients 25 years or older, with Type 2 Diabetes Mellitus confirmed by WHO criteria for type 2 diabetes
2. Patients freshly diagnosed as diabetics or those who were on oral hypoglycemic agents without insulin
3. Patients willing to give written informed consent.
4. Patients are fit and no need for any hospital administration.
5. Patients willing to perform all study related procedures including the use of study medicine, allow the physical and Biochemical tests and willing to document symptoms and medication.
 
 
ExclusionCriteria 
Details  1. Patients with renal impairment.
2. Patients will be also excluded if they have poorly controlled diabetes mellitus.
3. Female patients who are pregnant.
4. Unstable medical or psychiatric illness.
5. Chronic & acute disorders requiring hospital admission.
6. Known HIV-positive, Hepatitis B or C status.
7. Inability to carry out visits for the study.
8. Inability to maintain current medication regimen.
9. Inability or unwillingness to participate in all components of the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Assessment Questionnaire
2. Blood tests: FBG, PPBG, HbA1c
(From Baseline to 90 days of treatment) 		 1. Assessment Questionnaire
2. Blood tests: FBG, PPBG, HbA1c
(From Baseline to 90 days of treatment) 
 
Secondary Outcome  
Outcome  TimePoints 
1. Quality of Life
2. Drug safety: RFT & LFT
3. Incidence of Adverse events (AE) and Serious Adverse Events (SAE) during the study period
(From Baseline to 90 days of treatment) 		 From Baseline to 90 days of treatment 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   23/02/2023 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   After completion will be published in peer reviewed journal 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - None of the above

  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 - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  data requestors will need to sign a data access agreement after tht data will be provided by email

  6. For how long will this data be available start date provided 03-10-2023 and end date provided 02-10-2026?
    Response (Others) - 

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Post-marketing open label observational clinical study will be undertaken by investigator and his teams in Kolkata at 2 sites. Total no. of study patients 30 + 10% probable dropouts. Only those patients providing written informed consent will be enrolled for the study in specific centre. After receiving written consent, all patient will be assessed according to inclusion and exclusion criteria and then will be enrolled. Study materials will be provided to them free of cost for their regular use, along with specific information. Patients will be orally administered Micon Gold Capsule - 2 cap twice daily before food with lukewarm water for 90 days. Diet habit/ life style modification will also be guided. The patients will visit their specific centre at baseline and at end of the study for assessment. Statistical analysis will be done according to type of data and significance will be considered p less than 0.05. 
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