| CTRI Number |
CTRI/2019/04/018366 [Registered on: 01/04/2019] Trial Registered Prospectively |
| Last Modified On: |
01/04/2019 |
| 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 effect of Darvyadi ghee verses Darvyadi kwath in two group w.s.r.DM |
|
Scientific Title of Study
|
Randomised open comparative clinical trial for evaluating the efficacy of Darvyadi ghrita vs Darvyadi kashaya In vata pradhan prameha w.s.r to 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 Asha Malviya |
| Designation |
MD Scholar |
| Affiliation |
All India Institute of Ayurveda gautampuri saritavihar mathura road New Delhi |
| Address |
6 floor Academic block AIIA Gautampuri Saritavihar Mathuraroad New Delhi -110076
South
DELHI
110076
India |
| Phone |
8305809483 |
| Fax |
|
| Email |
ashamalviya0111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raja Ram Mahto |
| Designation |
Assistant proffesor |
| Affiliation |
All India Institute of Ayurveda gautampuri saritavihar mathura road New Delhi |
| Address |
6 floor Academic block AIIA Gautampuri Saritavihar Mathuraroad New Delhi -110076
South
DELHI
110076
India |
| Phone |
8877033663 |
| Fax |
|
| Email |
mahtorajaram88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V G Huddar |
| Designation |
Associate Proffesor |
| Affiliation |
All India Institute of Ayurveda gautampuri saritavihar mathura road New Delhi |
| Address |
6 floor Academic block AIIA Gautampuri Saritavihar Mathuraroad New Delhi -110076
South
DELHI
110076
India |
| Phone |
9986697942 |
| Fax |
|
| Email |
drvghuddar@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda Gautampuri,Saritavihar,Mathura road,New Delhi |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
All India Institute of Ayurveda Sarita vihar ,Gautampuri,Mathuraroad, New Delhi-110076 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Vitthal G Huddar |
All India Institute of Ayurveda |
OPD no 7 Of Kayachikita Hospital Blok Gautampuri Saritavihar Mathura road New Delhi-110076
South
DELHI |
9986697942
drvghuddar@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: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Darvyadi Ghrita
Darvyadi Kashaya |
Darvyadi ghrita will be prepared as mentioned in classics As mentioned in classics Darvyadi kashaya will be use
|
| Intervention |
Darvyadi ghrita 15ml,BD orally ,30 Days
Darvyadi Kashaya 20 ml,BD ,orally 30 Days |
Darvyadi ghrita will be prepared as mentioned in classics
As mentioned in classics Darvyadi kashaya will be use |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 BMI < 25
2 Significant weight loss.(Loss of 4.5 kg or
>5% of the usual body weight over a period of
6-12 month especially when progressive)
3 Fasting blood glucose – (126-250mg/dl)
4 PPBS (200-400 mg/dl)
|
|
| ExclusionCriteria |
| Details |
IDDM patients
FBS> 250mg/dl
PPBS> 400mg/dl
Gestational diabetes.
Patients on steroids.
Malignant and accelerated Hypertension.
CCF.
CHD
Pregnant women.
Lactating mother
Any other conditions interfering with the treatment of the condition.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of Darvyadi Ghrita and Darvyadi Kashaya by oral medication in vata pradhan Prameha with reference to subjects suffering from Diabetes Mellitus.
Decrease in vataja lakshna like krish, ruksh, alpashi, pipasubhrisham, parisaranshil, daurbala
Blood sugar level -FBS and PPBS
Urine analysis: fasting and PP sugar
Glycosylated Hb – (HbA1C)
|
one year one month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Lipid profile
Improvement in BMI
Waist Hip ratio.
Overall Improvement in Quality of life.
Improvement in Agni Bala, Deha Bala and Chetas Bala as per Ayurveda
|
zero,fifteenth,thirtyth 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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/05/2019 |
| 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="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
The thesis work will be publish in reputed journal |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Diabetes mellitus comprises a group of metabolic disorder share the common phenotype of hyperglycemia.
Diabetes mellitus is a syndrome of impaired carbohydrate, fat and protein metabolism
Acharya Charaka, has classified Prameha into two types, i.e. Sthula Pramehiviii and Krisha Pramehi .
Kaphaja and Pittaja Pramehas persisting for long time may present with predominance of Vata dosha, producing the features of vata pradhana prameha associated with dhatukshaya lakshanas.
in case of Vatapradhana prameha where acharyas have suggested the drugs in the form of Ghritas prepared out of the drugs mentioned for other type of pramehas so that atikarshana should not aggreviate vata and in turn no results by the treatment or worsening of the condition may be seen.
With this approach the Darvyadi ghrita is taken prepared out of the Kashaya drugs mentioned for all types of Prameha which will alleviate Kapha and pitta dosha aslo will take care so that vata prakopa should not occur and also alleviates it, resulting in remission of the condition.
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