| CTRI Number |
CTRI/2023/02/050111 [Registered on: 27/02/2023] Trial Registered Prospectively |
| Last Modified On: |
18/12/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To study the effect of diafyn in mild diabetes patients. |
|
Scientific Title of Study
|
A study on the efficacy of tablet Diafyn in Type 2 Diabetes Mellitus – A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yogeshwar Chippa |
| Designation |
Ayurveda research scientist |
| Affiliation |
sri sri institute of advanced research |
| Address |
Room no 3
Dept of Ayurveda
Sri Sri Institue of Advanced Research.
21st KM kanakapura road
Bangalore
Karnataka
Bangalore Rural
KARNATAKA
560082
India |
| Phone |
|
| Fax |
|
| Email |
drcyogeshwar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogeshwar Chippa |
| Designation |
Ayurveda research scientist |
| Affiliation |
sri sri institute of advanced research |
| Address |
Room no 3
Dept of Ayurveda
Sri Sri Institue of Advanced Research.
21st KM kanakapura road
Bangalore
Karnataka
Bangalore
KARNATAKA
560082
India |
| Phone |
|
| Fax |
|
| Email |
drcyogeshwar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yogeshwar Chippa |
| Designation |
Ayurveda research scientist |
| Affiliation |
sri sri institute of advanced research |
| Address |
Room no 3
Dept of Ayurveda
Sri Sri Institue of Advanced Research.
21st KM kanakapura road
Bangalore
Karnataka
Bangalore
KARNATAKA
560082
India |
| Phone |
|
| Fax |
|
| Email |
drcyogeshwar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri Institute for advanced research (SSIAR) |
|
|
Primary Sponsor
|
| Name |
Sri Sri Institute for advanced research (SSIAR) |
| Address |
Ved Vignan Maha Vidya Peeth, 21st Km Kanakapura Rd,Udayapura, Bengaluru, Karnataka 560082 |
| Type of Sponsor |
Other [VVMVP] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Abhishek Jaiswal |
Atharva multi speciality hospital and research centre |
OPD No 2
Dept of Diabetes and Endocrinology
Power house,H/4 Sector E Amarpali Yojana,Dubagga road,Near IIM Road,Lucknow,Uttar Pradesh 226000
Lucknow
UTTAR PRADESH |
9889441902
drabhishekarun@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Udyaan Healthcare |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: PRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Tab Diafyn, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1000(mg), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | 100% Starch | 100% Starch 1gm |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1) Newly diagnosed and those subjects on treatment of Type 2 Diabetes Mellitus
2) Age group between 25 to 55 years
3) Glycosylated hemoglobin (HbA1c) between 6.4% to 8 |
|
| ExclusionCriteria |
| Details |
1) Subjects with Type 1 Diabetes Mellitus
2) Subjects with established cases of Alcoholism and Drug abuse
3) Pregnant and lactating women.
4) Subjects with major renal and hepatic disorder |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Values of FBS PPBS LFT HbA1C will be assessed at the end of the study |
Baseline and end of 13 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The safety of the drug will be assessed throughout the study. |
Day0,Day90. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/02/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Type 2 Diabetes Mellitus is a metabolic disorder of chronic origin having elevated levels of blood glucose which leads to serious damage of various vital organs specially kidney, eye and nerves. This study was done to evaluate the efficacy and safety of Tablet Diafyn in patients suffering with Type 2 Diabetes Mellitus in achieving the glycemic control. It will be a Randomized Controlled Trial with 2 groups (Interventional arm and control arm), Randomization will be done through computer; allocation concealment and double blinding (investigator and patient) will be followed in the study. Drug compliance will be monitored through home visits by Medical Social Workers. Intervention group will be receiving Tab Diafyn 1gm thrice a day before food and control arm will be receiving Placebo 100% Starch 1 gm thrice a day before food. Starch can increase the blood sugar level, although slowly. Control arm patients also receive standard treatment for diabetes. Following investigations will be done on Day 0 and Day 90:- HbA1c, Fasting and Post Prandial blood sugar, Lipid Profile, B.Urea, S.Creatinine, AST and ALT.
|