| CTRI Number |
CTRI/2019/03/017952 [Registered on: 06/03/2019] Trial Registered Prospectively |
| Last Modified On: |
11/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic management of diabetes |
|
Scientific Title of Study
|
A comparative clinical study on the efficacy of vamana karma with ikshvaku yoga and darvyadi kwatha with life style modification in prameha w.s.r to prediabetes |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Santoshkumar Bhatted |
| Designation |
Associate Professor & HOD Panchakarma |
| Affiliation |
All India Institute of Ayurveda |
| Address |
All India Institute of Ayurveda gautampuri sarita vihar mathura road new delhi
New Delhi
DELHI
12345
India |
| Phone |
9414048459 |
| Fax |
|
| Email |
santoshbhatted@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santoshkumar Bhatted |
| Designation |
Associate Professor & HOD Panchakarma |
| Affiliation |
All India Institute of Ayurveda |
| Address |
All India Institute of Ayurveda gautampuri sarita vihar mathura road new delhi
New Delhi
DELHI
12345
India |
| Phone |
9414048459 |
| Fax |
|
| Email |
santoshbhatted@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Santoshkumar Bhatted |
| Designation |
Associate Professor & HOD Panchakarma |
| Affiliation |
All India Institute of Ayurveda |
| Address |
All India Institute of Ayurveda gautampuri sarita vihar mathura road new delhi
New Delhi
DELHI
12345
India |
| Phone |
9414048459 |
| Fax |
|
| Email |
santoshbhatted@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda sarita vihar mathura road new delhi |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
All India Institute of Ayurveda gautampuri sarita vihar mathura road new delhi |
| 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 Uttamram Yadav |
OPD and IPD |
All India Institute of Ayurveda
South
DELHI |
7566641503
druttamram@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E139||Other specified diabetes mellituswithout complications, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Darvyadi Kwatha |
No vamana karma, darvyadi kwatha will life style modification will be advised |
| Intervention |
Vamana Karma with Ikshvaku Yoga |
Vamana Karma will be followed by Darvyadi Kwatha Shamana for 15 days |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age between 30 years to 60 years
obese pattients
HBA1c between 5.7% - 6.4%
Fasting blood glucose 100 - 125mg/dl
BMI>25
waist to hip ratio in male>0.95 and female>0.80 |
|
| ExclusionCriteria |
| Details |
IDDM patients
Gestational diabetes
Patients on steroids or oral Hypoglycemic drugs
Malignant and accelerated Hypertension
CCF
Pregnant women
Lactating mother
Any serious disease condition
Patients who are unfit for Vamana karma
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of Vamana karma followed by Darvyadi kwatha with that of only oral medication of Darvyadi kwatha with life style modification (Nidana pariverjana) in reducing FBS PPBS and HbA1C of the subjects suffering from Pre-Diabetes (Prameha) |
120 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvement in subjective and objective parameters and quality of life |
120 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/ Phase 2 |
|
Date of First Enrollment (India)
|
18/03/2019 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A comparative clinical study on the efficacy of vamana karma with ikshvaku yoga and darvyadi kwatha with life style modification in prameha w.s.r to prediabetes
RESEARCH QUESTION
Does either
the use of Vamana karma followed by
the oral administration of Darvyadi kwatha or the use of only Darvyadi kwatha without Vamana karma with the life style
modification (Nidana parivarjana)
have equal efficacy in managing Prameha w.s.r
to Pre-Diabetes?
HYPOTHESIS
Vamana karma followed by the
oral administration of Darvyadi kwatha in
the dose of 80ml BD for 30 days before food has greater efficacy as compared
with that of the only use of oral administration of Darvyadi kwatha in the dose of 80ml BD for 30 days before food with
the life style modification in managing Prameha
w.s.r to Pre-Diabetes.
NULL
HYPOTHESIS- Vamana karma followed by Darvyadi kwatha do not have efficacy in
comparison with that of oral administration of Darvyadi kwatha
and the life style modification (Nidana parivarjana) in the management of Pre-Diabetes.
ALTERNATE
HYPOTHESIS- Vamana karma followed by Darvyadi kwatha has more efficacy than oral administration of Darvyadi kwatha and
the life style modification in the management of Prameha w.s.r to Pre-Diabetes.
SETTING
Clinical
setup- OPD and IPD of AIIA, New Delhi.
Group A:
Classical Vaman karma with Ikshvaku yoga in schedule for 15 days followed by the oral
administration of Darvyadi kwatha in
the dose of 80ml twice a day before food with life style modification (Nidana pariverjana) for 1 month.
Group B:
Oral administration of Darvyadi kwatha in the dose
of 80ml twice a day before food with life style modification (Nidana pariverjana) for 1 month.
SAMPLE SIZE AND CALCULATION-
With the lack of abundance in the literature (published Research
articles), the proposed research project may be considered to be a Pilot
Prospective study. Hence a sample size of 20 subjects per group will be
enrolled in the study[15].
PROCESS OF RANDOMIZATION:
An unbiased and block
Randomization using computer generated random number.
CRITERIA FOR SELECTION
INCLUSION CRITERIA
·
Age between 30 years to 60 years.
·
Obese Patients.
·
HBA1C between 5.7% - 6.4%.
·
Fasting blood glucose 100 - 125mg/dl.
·
BMI > 25.
·
Waist to hip ratio
In case of Male > 0.95 In case of Female > 0.80
EXCLUSION CRITERIA
·
IDDM patients.
·
Gestational diabetes.
·
Patients on steroids or oral Hypoglycemic drugs.
·
Malignant and accelerated Hypertension.
·
CCF.
·
Pregnant women.
·
Lactating mother.
·
Any serious disease condition.
·
Patients who are unfit for Vamana karma.
CRITERIA FOR DIAGNOSIS
·
HBA1C between 5.7% - 6.4%
·
Fasting plasma glucose 100mg/dl - 125mg/dl
·
Oral glucose tolerance test(OGTT) 140mg/dl - 200mg/dl
·
BMI
GROUPING AND DRUG DELIVERY
REGIMEN (DRUG, DOSE DURATION, FOLLOW-UP, WITHDRAWAL CRITERIA, RESCUE
MEDICATION)
The following is the proposed graphical tree of the
study design.
Setting and Location: OPD & IPD, AIIA
Eligible subjects with submission of written ethical
permission
|
Follow-up upto 120 day
Follow-up will be
done on 46th 76th 106th & 120th days.
|
Darvyadi kwatha in the dose of 80ml two
times a day
before food with
life style modification (Nidana pariverjana) for 1 month.
|
|
Classical
Vamana karma (it includes use of
Pachana,Deepana Abhyanga,Swedana & Vamana karma followed by samsarjana krama) approximate duration of
15 days.
|
|
|
|
|
|
Darvyadi kwatha in the dose
of 80ml twice a day before
food with life
style modification (Nidana
pariverjana)
for 1 month.
|
|
|
|
|
Follow-up upto
120 day Follow-up will
be done on 46th 76th 106th & 120th days.
|
|
|
|
|
|
Proposed Timeline of
data collections, analyses, interpretations and report submission: Pl
refer to Table- 2.
|
DRUGS AND DURATION:
The same are stated in Table
-1.
Table – 1
Proposed
therapeutic procedures, drugs doses and time schedule
|
Procesure
|
Duration
|
Medicine
|
Dose
|
Time
|
|
Deepana & Pachana
|
3 - 7
days (as per
requirement)
|
Nagarmotha Panchakola
|
5gm 5gm
|
TDS
|
|
Snehapana
|
3 – 7
days (as per requirement)
|
Murchhita ghrita
|
Increasing
|
6am – 8am
|
|
Abhyanga
|
2 days
|
Tila taila
|
100ml
|
After Snehpana
|
|
Bashpa Swedana
|
2 days
|
Dashmoola kwatha
|
50gm
|
After
Abhyanga
|
|
Vamana
|
1 day
|
Classical Ikshvaku yoga
|
6gm and conventional drugs of Vamana karma
|
After sunrise 6am – 8am
|
|
Sansajgana Krama
|
3 – 7
days (as per requirement)
|
Peya, Vilepy Akrita yush Krita yush
|
According to Agni bala
|
lunch Dinner
|
|
Samshamana medicine
|
30 days
|
Darvyadi kwatha
|
80ml twice a days
|
Before food
|
Before Vamana karma Sarvanga Abhyanga will be
done with Tila Taila & Mridu Bashpa Swedana will be done with Dashamoola Kwatha.
Drugs will be procured as per the
policies of AIIA
DURATION: 120 days
FOLLOW-UP: upto 90 day; once in month and Follow-up
will be done
on 46th
76th 106th & 120th
days.
Total number of follow-up is 4.
|