| CTRI Number |
CTRI/2019/04/018729 [Registered on: 24/04/2019] Trial Registered Prospectively |
| Last Modified On: |
22/04/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of nyagrodhadi churna and b-s patra ghana vati in diabetic patients. |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the efficacy of nyagrodhadi churna & b-s patra ghana vati in the management of madhumeha w.s.r 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 op singh |
| Designation |
H.O.D and professor of kayachitisa department |
| Affiliation |
Rishikul ayurvedic college |
| Address |
P.G department of kayachikitsa Rishikul campus uau haridwar.
P.G department of kayachikitsa Rishikul campus uau haridwar.
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9411503035 |
| Fax |
|
| Email |
dr.opsingh63@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr op singh |
| Designation |
H.O.D and professor of kayachitisa department |
| Affiliation |
Rishikul ayurvedic college |
| Address |
P.G department of kayachikitsa Rishikul campus uau haridwar.
P.G department of kayachikitsa Rishikul campus uau haridwar.
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9411503035 |
| Fax |
|
| Email |
dr.opsingh63@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr op singh |
| Designation |
H.O.D and professor of kayachitisa department |
| Affiliation |
Rishikul ayurvedic college |
| Address |
P.G department of kayachikitsa Rishikul campus uau haridwar.
P.G department of kayachikitsa Rishikul campus uau haridwar.
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9411503035 |
| Fax |
|
| Email |
dr.opsingh63@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rishikul campus uau haridwar |
|
|
Primary Sponsor
|
| Name |
Rishikul campus |
| Address |
Rishikul campus uau haridwar |
| 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 |
| Vipul bartwal |
Rishikul ayurvedic college haridwar |
P.G department of kayachikitsa Rishikul campus uau haridwar.
Hardwar
UTTARANCHAL |
9634747002
dr.vipulbartwal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical commitee |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A |
Nyagrodhadi churna 5gm BD with Triphala Kwath 30 minute before meal Orally for 60 days.
|
| Comparator Agent |
Group B |
B-S Patra Ghana Vati 500 mg BD with luke warm water 30 minute before meal orally for 60 days. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
fasting blood glucose level > 110mg/dl-250mg/dl
post Prandial blood sugar level > 140 mg/dl-350mg/dl |
|
| ExclusionCriteria |
| Details |
patients of type 1 diabetes mellitus
fasting blood glucose level> 250 mg/dl
post prandial blood glucose level > 350 mg/dl
patients having complication
other serious medical & surgical ill patient
patient cannot follow the dietary regime
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
o assess the effect of therapy, objectively all signs and symptoms were given scoring depending upon their severity
No improvement- 25% improvement
Mild improvement- 25% to 50%
Moderate improvement-50% to 75% improvement
Marked improvement- 75% improvement
Complete improvement-100% improvementT |
Duration of study- 60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
to assess the effect of therapy, objectively all signs and symptoms were given scoring depending upon their severity
No improvement- 25% improvement
Mild improvement- 25% to 50%
Moderate improvement-50% to 75% improvement
Marked improvement- 75% improvement
Complete improvement-100% improvement |
Duration of study- 60 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 1 |
|
Date of First Enrollment (India)
|
04/05/2019 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
40 Patients of Madhumeha( diabetes mellitus) will be selected for study from O.P.D/I.P.D unit of P.G department of kayachikitsa , UAU, Rishikul campus, haridwar. These patients will be randomly divided on 2 groups that mean 20 patients in each group on the basis of criteria of inclusion and exclusion with blood sugar examination, detailed clinical history and physical examination and other necessary/desired investigations. GROUP A- 20 Patient will be subjected through Nyagrodhadi churna 5gm B.D with Triphala Kwath 30 minute before meal. GROUP B- 20 Patient will be subjected through B-S Patra Ghana Vati 500 mg B.D with luke warm water 30 minute before meal. Duration of study- 60 days |