| CTRI Number |
CTRI/2021/05/033681 [Registered on: 18/05/2021] Trial Registered Prospectively |
| Last Modified On: |
09/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study of Chitraktriphladi Kashayam with madhu and Chitraktriphladi Kashayam Ghana vati in Diabetes. |
|
Scientific Title of Study
|
“A Randomized Clinical Comparative Study on Chitraktriphaladi Kashayam with Madhu and Chitraktriphaladi Kashayam Ghana Vati in the Management Of Madhumeha 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 Parveen Sharma |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda, Jaipur |
| Address |
P.G. Department of Kayachikitsa
National Institute of Ayurveda,Jaipur-302002
National Institute of Ayurveda , Madhav Vilas, Amer Road, ,Jaipur-302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
9068000101 |
| Fax |
|
| Email |
drparveensharma44@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Kumar Sahu |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
P.G. Department of Kayachikitsa
National Institute of Ayurveda,Jaipur-302002
National Institute of Ayurveda , Madhav Vilas, Amer Road, ,Jaipur-302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
9950708106 |
| Fax |
|
| Email |
drajaysahu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parveen Sharma |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
P.G. Department of Kayachikitsa
National Institute of Ayurveda,Jaipur-302002
National Institute of Ayurveda , Madhav Vilas, Amer Road, ,Jaipur-302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
9068000101 |
| Fax |
|
| Email |
drparveensharma44@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda, Jaipur( 302002 ) |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda Jaipur |
| Address |
Jorawar Singh Gate, Amer Road, Jaipur , 332002 ( Rajasthan ) |
| 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 Parveen Sharma |
National Institute of Ayurveda and Hospital |
OPD No 1,7,18,22,25, Arogyasala , PG Department of Kayachikitsa, NIA, Jorawar Singh Gate, Amer Road, Jaipur 302002 ( Rajasthan )
Jaipur
RAJASTHAN |
9068000101
drparveensharma44@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee National Institute of Ayurveda |
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/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chitraktriphaladi Kashayam Ghana Vati |
Orally, Twice a day before meal for 30 days with luke warm water
( Dosage will be decided as per extract obtained from kwatha) |
| Intervention |
Chitraktriphaladi Kashayam With Madhu |
Orally , 40 ml BD before meal for 30 days |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients giving the clinical history of DM (Type II).
2. Patients having hyperglycaemia confirmed by laboratory investigations i.e. Fasting
Blood Sugar (FBS) ≥ 126mg/dl or Post Prandial Blood Sugar (PPBS) ≥ 140-300 mg/dl
3. Presence of Cardinal symptoms of Diabetes Mellitus eg. (3P- polyuria, polydypsia, polyphagia).
|
|
| ExclusionCriteria |
| Details |
i. Patients below 30 years of age & above 70 years of age.
ii. Patients having Type I DM.
iii. Patients of Type II DM who are on insulin therapy.
iv. Patients having any serious illness like Coronary Artery Disease, malignancy, hypertension > 140/90 mm of Hg etc.
v. Drug induced DM.
vi. F.B.S. > 200 mg/dl and P.P.B.S. > 300 mg/dl.
vii. Patients having chronicity of more than 5 years.
viii. DM with complications.
ix. Pregnant and lactating mother
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in Cardinal Symptoms of Type -II Diabetes Mellitus ( Madhumeha ) |
30 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in the objective parameters. |
30 Days |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/08/2021 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
AIMS
& OBJECTIVES:
1.
To assess clinical efficacy of Chitraktriphladi Kashayam with Madhu in
the management of a series of patients suffering from Madhumeha (DM Type II).
2.
To assess clinical efficacy of Chitraktriphladi Kashayam Ghana Vati in
the management of a series of patients suffering from Madhumeha (DM Type II).
To compare the
efficacy of Chitraktriphaladi Kashayam
with Madhu and Chitraktriphaladi Kashayam Ghana Vati in the management of Madhumeha (DM Type II).
HYPOTHESIS
Null
hypothesis [H0]:
Chitraktriphaladi Kashayam
with Madhu and Chitraktriphaladi
Kashayam Ghana Vati are equally effective in the Management Of Madhumeha (Type-2 Diabetes Mellitus).â€
MATERIALS &
METHODS
Following materials and methods will be employed
for conducting the present research work-
CLINICAL STUDY
Following materials and
methods will be employed for conducting the present research work-
Selection of Cases:
§ The
study will be conducted in 30 clinically diagnosed and confirmed patients of Madhumeha (Type II Diabetes Mellitus)
from OPD/IPD of NIA hospital, Jaipur. These patients will be randomly divided
into two groups - Group A, Group B with 15
patients in each group.
Diagnostic
Criteria
§ Diagnosis based
on presenting clinical features of Madhumeha
(Type II DM).
§ Subjects with FBS
> 126 mg/dl, PPBS > 140-300 mg/ dl
Study
Design:
The present study is
supposed to be-
·
Level of study : OPD/IPD
·
Study type : Interventional,
Single Centre
·
Purpose : Treatment
·
Masking : Open Label
·
Timing : Prospective
·
End point : Safety and efficacy
·
No. of groups : Two (15
patients in each group)
No. of
patients 30·
Duration of Study : 30 days
·
Follow-up : 15th
day, 30th day after initial assessment.
|