| CTRI Number |
CTRI/2020/03/024195 [Registered on: 24/03/2020] Trial Registered Prospectively |
| Last Modified On: |
13/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of nishakatkadi ghan vati with oral hypoglycemic agent in the treatment of diabetes mellitus |
|
Scientific Title of Study
|
A Randomized Controlled clinical study to evaluate an adjuvant effect of Nishakatkadi Ghan vati with oral Hypoglycemic agent in diabetes Mellitus (type2) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sandip shivaji bhorje |
| Designation |
PG Studant |
| Affiliation |
PDEAs college of ayurved and research centre akurdi |
| Address |
PDEAs college of ayurved and research centre akurdi sec.25 pune ayurved rugnalay and sterling multispecility hospital sec.27 nigdi pradhikaran pune 44
PDEAs college of ayurved and research centre akurdi sec.25 pune ayurved rugnalay and sterling multispecility hospital sec.27 nigdi pradhikaran pune 4
Pune
MAHARASHTRA
4110044
India |
| Phone |
8788106418 |
| Fax |
|
| Email |
sandipbhorje659@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrMedha Mahesh Joshi |
| Designation |
Guide and HOD of kaychikitsta department |
| Affiliation |
PDEAs college of ayurved and research centre akurdi |
| Address |
PDEAs college of ayurved and research centre akurdi sec.25 pune ayurved rugnalay and sterling multispecility hospital sec.27 nigdi pradhikaran pune 44
PDEAs college of ayurved and research centre akurdi sec.25 pune ayurved rugnalay and sterling multispecility hospital sec.27 nigdi pradhikaran pune 44
Pune
MAHARASHTRA
4110044
India |
| Phone |
9881465798 |
| Fax |
|
| Email |
medhamaheshjoshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrMedha Mahesh Joshi |
| Designation |
Guide and HOD of kaychikitsta department |
| Affiliation |
PDEAs |
| Address |
PDEAs college of ayurved and research centre akurdi sec.25 pune ayurved rugnalay and sterling multispecility hospital sec.27 nigdi pradhikaran pune 44
PDEAs college of ayurved and research centre akurdi sec.25 pune ayurved rugnalay and sterling multispecility hospital sec.27 nigdi pradhikaran pune 44
Pune
MAHARASHTRA
4110044
India |
| Phone |
9881465798 |
| Fax |
|
| Email |
medhamaheshjoshi@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs college of ayurveda and Research centre 3rd floor kaychikitsa depratment nigdi pradhikarn sector 25 pune 44 |
|
|
Primary Sponsor
|
| Name |
Principal PDEAs college of Ayurved and Research centre |
| Address |
PDEAs college of ayurved and research centre nigdi pradhikaran sec.25 pune 411044 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Drsandip Shivaji Bhorje |
Ayurveda Rungalay And Sterling Multispeciality Hospital Nigdi opd no.117 |
vitthalrukhmini road,sec.27 akurdi pradhikaran 411044 opd kaychikitsa opd no.15
Pune
MAHARASHTRA |
8788106418
Sandipbhorje659@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nishakatkadi Ghan vati |
Nishakatkadi Ghan vati is preapared by vati kalpana and will be givan orally 500mg before breakfast,lunch and dinner day with luke warm water which includes followup on every 15th day till 3 months. |
| Comparator Agent |
Oral hypoglycemic agent |
Oral hypoglycemic agent As prescribed by physician . |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Age group between 35 years to 70 years
2.cases of both gender will be included
3.patient with fasting blood sugar upto 200 mg% and post parandial blood sugar 300mg% |
|
| ExclusionCriteria |
| Details |
1.insulin dependent diabetes mellitus (IDDM)and those who are under insulin therapy.
2.patient with acute complications like hyperglycemic and hypoglycemic coma,ketoacidosis and related complication and infections like gangrene.
3.patient with chronic diabetic complications like Nephropathy,Neuropathy and Retinopathy.
4.pregnant and lactating woman.
5.patients suffering from all major systemic diseases |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate efficacy of Nishakatkadi Ghan Vati 500mg three times before breakfast,lunch and dinner a day for 3 months as an adjuvant medication to oral hypoglycemic agent in the management of diabetes mellitus type 2on basis of BSL and HbA1C values |
90 Days with follow up on every 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.to study the effect of Nishakatkadi Ghan vati 90days.
2.to study the effect of oral Hypoglyacemic agent.
3.to observe the adverse effect if any |
90 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 2 |
|
Date of First Enrollment (India)
|
01/04/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
prameha is disease well known sine vedic period.prameha,which is known to world as diabetes,is global helth problems,it is metabolic disorder, which includes sign and symptoms of prabhutavilmutrata,daurbalya,kshudhavruddhi pipasaadhikya.etc nishakathkadi ghanvati in mentioned in shahasrayogum,drugs is havingantihyperglycemic effect,antilipidemic action,kledhagna,kafgna properties
hence this drug will be used in DM2. |