| CTRI Number |
CTRI/2021/06/034030 [Registered on: 07/06/2021] Trial Registered Prospectively |
| Last Modified On: |
24/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of Neelkanthi churna in Madhumeha w.s.r to Type 2 Diabetes Mellitus |
|
Scientific Title of Study
|
A preclinical and clinical study to determine the efficacy of Neelkanthi Churna in management of Madhumeha w.s.r to 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 Vijay Chaudhary |
| Designation |
HOD Kayachikitsa department |
| Affiliation |
R.G.G.P.G Ayurvedic College, Paprola |
| Address |
RGGPG Ayurvedic College and Hospital Paprola Mahalaxmi traders Near KCC bank VPO Paprola Teh Baijnath Distt Kangra
RGGPG Ayurvedic College and Hospital Paprola Mahalaxmi traders Near KCC bank VPO Paprola Teh Baijnath Distt Kangra
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418130228 |
| Fax |
|
| Email |
drvijaychaudhary@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Vijay Chaudhary |
| Designation |
H O D |
| Affiliation |
R G G P G Ayurvedic College and Hospital |
| Address |
Room 315
Kayachikitsa Department
R G G P G Ayurvedic College and Hospital Paprola Kangra
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418130228 |
| Fax |
|
| Email |
drvijaychaudhary@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shivali Mehra |
| Designation |
PG Scholar |
| Affiliation |
R G G P G Ayurvedic College and Hospital |
| Address |
Room 315
Kayachikitsa Department
R G G P G Ayurvedic College and Hospital Paprola Kangra
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
7876441151 |
| Fax |
|
| Email |
shivalimehra450@gmail.com |
|
|
Source of Monetary or Material Support
|
| Baijnath pharmacy,Paprola District Kangra,Himachal Pradesh |
|
|
Primary Sponsor
|
| Name |
Principal |
| Address |
RGGPG Ayurvedic College and Hospital Paprola |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| ProfVijay Chaudhary |
R.G.G.P.G Ayurvedic College and Hospital |
Room No 315
Kayachikitsa Department
R.G.G.P.G Ayurvedic College & Hospital, Paproal
Kangra
HIMACHAL PRADESH |
9418130228
drvijaychaudhary@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC(human)RGGPG Ayurvedic College Paprola |
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: MADHUMEHAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Neelkanthi Churna |
Neelkanthi Churna 3 g twice a day orally for 12 weeks duration |
| Comparator Agent |
Tab. Metformin |
Tab. Metformin 1 g Twice a day orally for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients of either sex aged between 20-70yrs.
2) Newly diagnosed patients of Type 2 Diabetes Mellitus having glycosylated Hb (HbA1C) between 6.5% to 10%
3) Patients willing to participate in the trial. |
|
| ExclusionCriteria |
| Details |
Subject of Type-1 DM or Type-2 DM on insulin/OHA’s other than Metformin/ any other medication for glucose control in the last 3 months
Subjects suffering from the complications of Diabetes Mellitus viz., diabetic neuropathy, diabetic nephropathy, diabetic retinopathy etc. which require an urgent treatment.
Patients having major medical illness like cancer, concurrent infection like tuberculosis.
Patients with uncontrolled Hypertension.
Patients with established diagnosis of CAD or any other clinically significant cardiovascular disease.
Renal dysfunction (defined by eGFR< 60ml/min calculated by MDRD calculator)
Subjects who have completed participation in any other clinical trial during the past 3 months.
Any other condition which the investigator thinks may compromise the safety of subject.
Subjects with Haemoglobin percentage < 9gm% for males and < 8gm%for females.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fulfillment of objective and subjective criteria |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Efficacy of Neelkanthi Churna in type 2 Diabetes Mellitus |
12 weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
17/06/2021 |
| 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="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
I would like to publish my research trial after completion of the trial as soon as possible. Patients will selected from OPD & IPD of R.G.G.P.G Ayurvedic College & Hospital Paprola. 3 groups of 30 patients will be registered then assessed to evaluate the efficacy of Neelkanthi Churana in Madhumeha w.s.r Diabetes Mellitus Type 2 |