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CTRI Number  CTRI/2025/01/079791 [Registered on: 30/01/2025] Trial Registered Prospectively
Last Modified On: 28/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Siddha 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Effect of D-Co-D for the management of type 2 diabetes 
Scientific Title of Study   Clinical evaluation of D-Co-D as stand-alone and with conventional therapy for the management of type 2 diabetes mellitus and improvement in various comorbidities parameters  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
DCOD/35/24 Ver 1.0  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr M Sakthi Balan MD 
Designation  Consultant 
Affiliation  DK Elite Health Care Centre 
Address  DK Elite Health Care Centre, First Floor, 370, Cuddalore Road, Nainar Mandapam, Velrampet, Puducherry, 605004

Pondicherry
PONDICHERRY
605004
India 
Phone  9843591097  
Fax    
Email  saheerose@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr M Sakthi Balan MD 
Designation  Consultant 
Affiliation  DK Elite Health Care Centre 
Address  DK Elite Health Care Centre, First Floor, 370, Cuddalore Road, Nainar Mandapam, Velrampet, Puducherry, 605004


PONDICHERRY
605004
India 
Phone  9843591097  
Fax    
Email  saheerose@gmail.com  
 
Details of Contact Person
Public Query  
Name  Gayathri Sivakumar 
Designation  Director 
Affiliation  KI3 PRIVATE LIMITED 
Address  No. 5/3,Jayalakshmi Street, Radha Nagar, Chromepet, Chennai- 600 044 Tamil Nadu, India.

Chennai
TAMIL NADU
600044
India 
Phone  09003109416  
Fax    
Email  drgayathri@ki3services.com  
 
Source of Monetary or Material Support  
Dr.JRKs Research and Pharmaceuticals Pvt Ltd,11 Perumal Koil Street Kunrathur, Chennai - 600 069, INDIA  
 
Primary Sponsor  
Name  Dr.JRKs Research and Pharmaceuticals Pvt Ltd 
Address  11 Perumal Koil Street Kunrathur, Chennai - 600 069, INDIA.  
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 
Dr Sakthi Balan  DK Elite Health Care Centre  First Floor, 370, Cuddalore Road, Nainar Mandapam, Velrampet, Puducherry, 605004
Pondicherry
PONDICHERRY 		 09843591097

saheerose@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHIQUE DE LA NATURE ASSOCIATION  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  D-Co-D tablet Each tablet (500mg) contains Nilavembu (Andrographis paniculata) : 100 mg Naval (Syzygium cumini) : 50 mg Seenthil (Tinospora cordifolia) : 50 mg Pagal (Momordica charantia) : 50 mg Koraikizhangu (Cyperus rotundus) : 50 mg Sukku (Zingiber officinale) : 50 mg Milaghu (Piper nigrum) : 50 mg Adathodai (Adhatoda vasica) : 50 mg Excipients : Q.S   Duration : One Tablet Per day for a total period of 6 months 
Comparator Agent  Iron tablet (siddha) + Metformin + Vidagliptin   Duration : One Tablet Per day for a total period of 6 months 
Intervention  JRK D-Co-D tablet + Metformin + Vidagliptin Each tablet (500mg) contains Nilavembu (Andrographis paniculata) : 100 mg Naval (Syzygium cumini) : 50 mg Seenthil (Tinospora cordifolia) : 50 mg Pagal (Momordica charantia) : 50 mg Koraikizhangu (Cyperus rotundus) : 50 mg Sukku (Zingiber officinale) : 50 mg Milaghu (Piper nigrum) : 50 mg Adathodai (Adhatoda vasica) : 50 mg Excipients : Q.S   Duration : One Tablet Per day for a total period of 6 months 
Comparator Agent  Madhumeghachoornam + Metformin + Vidagliptin Each 500mg tablet contains Terminalia chebula : 100mg Murraya koenigi : 100mg Emblica officinalis : 100mg Eugenia jambolana : 50 mg Tinospora cordifolia : 50 mg Phyllanthus amaras : 50 mg Cyperus rotundus : 50 mg Excipients : Q.S   Duration : One Tablet Per day for a total period of 6 months 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. People who are clinically proven for diabetes mellitus (type 2)
2. The duration of the disease between -1-15 years with the age ranged between 35-70 years
3. Predominantly on Metformin +Vidagliptin treatment for last 5 months
4. Also consulting AYUSH vaid besides diabetologist for AYUSH supplements which is not
been objected by the respective diabetologist
5. Willing to use JRK’s D-Co-D tablet as per the direction without altering or deviating the
main line therapy (Metformin + Vidagliptin)
6. The patients who have not shown serious concern on any of the laboratory test parameters
that may warrant the patient to be referred to specialized treatment
7. Patients who are willing to subject to certain laboratory investigations at entry level, 45
days, three and six month of therapy to ascertain treatment response
8. Patients who agree to the CRO and Sponsor to review and use the laboratory test results
obtained purely for research purpose, without divulging the identity of the patient and
where the medical benefit of JRK’s D-Co-D can be reached out to large section of
patients in India and other countries
9. Patients who agree to consult the respective diabetologist without fail; where participation
in the present observational study will not be construed by the patient such regular
consultation of the diabetologist is not require 
 
ExclusionCriteria 
Details  1. Not agreed to any of the criteria mentioned above
2. Lactating female and pregnant women
3. Patients who may be suffering from infection, other health complications that may require
primary medical attention 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1) Blood glucose profile of patients
2) Fasting blood glucose -FBG
3) Post prandial blood glucose -PPBG
4) Random blood glucose -RBG
5) Glycated haemoglobin -HbA1c
6) Na
7) K
8) Urea
9)Creatinine
10) Uric acid
11) Total protein
12) Albumin
13)Bilirubin
14) Alkaline phosphatase
15)Acid
phosphatase
16)Amylase
17)Total cholesterol,
18) Triglyceride
19) Vit B12
20) Na in urine
21) K in urine
22)Creatinine in urine
23) Systolic and Diastolic blood pressure 		 On day zero, after 45 days, after 3 months and after 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
1) Patient and Investigator Feedbacks will be obtained
2) Adverse event monitoring 		 On day zero, after 45 days, after 3 months and after 6 months 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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 3 
Date of First Enrollment (India)   12/02/2025 
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="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 - NO
Brief Summary   After getting informed consent, 300 subjects will be divided as per the below group

1) Group 1- JRK D-co-D tablet+ Metformin+ Vidagliptin
2) Group 2- Madhumeghachoornam+ Metformin+ Vidagliptin
3) Group 3- Iron tablet ( Siddha) + Metformin + Vidagliptin
4) D-co-D alone

All the patients alloted in each group based on randomization will be treated with the respective drug (s) for a total period of 6 months. All the blood and organ health parameter will be evaluated on day zero, after 45 days, after 3 months and after 6 months and the treatment response in each group was analysed for statistical signficance.

Evaluation Parameters
1) Fast blood Glucose 2) Post prandial blood glucose
3) Random blood glucose 4) Glycated Haemoglobin

Organ Health Details : Na, K, Urea, Creatinine, Uric Acid, Total Protein, Albumin, Bilieubin, Alkaline Phosphatase,Acid Phosphatase, Amylase, Total Cholestrol, Triglyceride, Vit B12, Na in Urine, K oin Urine, Creatinine in Urine, Systolic blood pressure and Diastolic blood Pressure
 
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