| CTRI Number |
CTRI/2018/05/013914 [Registered on: 16/05/2018] Trial Registered Prospectively |
| Last Modified On: |
28/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
USE OF SHISHAM LEAVES AND HEARTWOOD IN DIABETES |
|
Scientific Title of Study
|
A comparative study of Shimshapa kanda-sara and Patra
in the management of Madhumeha |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR JANKI M LUKHI |
| Designation |
M.D.SCHOLAR SECOND YEAR |
| Affiliation |
Government Ayurved college, Vadodara. |
| Address |
POST GRADUATE DEPARTMENT OF DRAVYAGUNA ,
GOVERNMENT AYURVED COLLEGE
AJWA ROAD DHANVANTARI MARG
PANIGATA
VADODARA 390019
Vadodara
GUJARAT
390019
India |
| Phone |
8758810939 |
| Fax |
|
| Email |
jankilukhi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RAMESHCHANDRA PANDEY |
| Designation |
H.O.D AND PROFESSOR |
| Affiliation |
Government Ayurved college, Vadodara. |
| Address |
Post graduate department of Dravyaguna,Government Ayurved College, Dhanvantari marga, Ajwa road, Panigate, Vadodara,390019
Gujarat,India
Vadodara
GUJARAT
390019
India |
| Phone |
9724824168 |
| Fax |
|
| Email |
0901rcp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR NEHA PARMAR |
| Designation |
Assistant professor |
| Affiliation |
Government Ayurved college, Vadodara. |
| Address |
Post graduate department of Dravyaguna,Government Ayurved College, Dhanvantari marga, Ajwa road, Panigate, Vadodara,390019
Vadodara
GUJARAT
390019
India |
| Phone |
9558819463 |
| Fax |
|
| Email |
Nehaa.parmarr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurved college and Hospital |
|
|
Primary Sponsor
|
| Name |
Government Ayurved Hospital Vadodara |
| Address |
GOVERMENT AYURVED HOSPITAL
AJWA ROAD DHANVANTARI MARG
PANIGATE
VADODARA -390019 |
| 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 |
| Dr Janki M Lukhi |
OPD AND IPD Dravyaguna Department Government Ayurved Hospital , Vadodara |
PG-2 OPD AND OPD NO.-5
Dept. of Dravyaguna ,
Vadodara
GUJARAT |
8758810939
jankilukhi@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 |
WITH SYMPTOMS OF Madhumeha (type 2 Diabetes), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Shimshapa heartwood((Dalbergia sissoo Roxb.) |
3 gms churna with warm water two times before food for 6 weeks |
| Comparator Agent |
Shimshapa leaves (Dalbergia sissoo Roxb.) |
3 gms churna with warm water two times before food for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with classical sign and symptoms of Madhumeha like Prubhuta mutrata, Aavila mutrata, Kara- pada daha, Trishna and others. |
|
| ExclusionCriteria |
| Details |
1) Patients having age less than 25 years and more than 70 years.
2) Patients suffering from IDDM, uncontrolled HTN, Drug induced or uncontrolled dyslipidemia, clinical features of CCF, Hypothyroidism
3) Patient having systemic illness like tuberculosis, carcinoma and endocrine disorders or major illness like renal or liver disorder.
4) Pregnant & lactating women.
5) Patients of Juvenile type of DM.
6) Patient having terminal stage of the disease.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in the classical symptoms of madhumeha |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| change in the investigative report of urine and blood sugar |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/06/2018 |
| Date of Study Completion (India) |
27/12/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
To Evaluate The Efficacy Of Shimshpapatra Comapair With Shimshapakandsara In Madhumeha W.S.R To Diabetes Mellitus.
Dr. Janki Lukhi, , Dr.R.C.Pandey , Dr.Neha Parmar Dr. Dilip Jani
World Journal Of Pharmaceutical Research. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is a Randomized clinical trial to evaluate the effect of Shimshapa leaves powder and heartwood powder in the management of madhumeha(Type 2 Diabetes). Total 30 patients will be enrolled in present Study. Selected patients will be divided in 2 group on the basis of computer generated randomization. In this study shimshapa leaves powder will be given in dose 3gms bds before food with warm water for 6 weeks and shimshapa heartwood powder will be given in dose 3gms bds before food with warm water for 6 weeks. Follow up will be carried for 2 weeks. clinical data obtained will be summarized at the end of the study. Conclusion will be made after the statistical analysis of the data. |