CTRI Number |
CTRI/2021/07/035183 [Registered on: 27/07/2021] Trial Registered Prospectively |
Last Modified On: |
23/07/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda Yoga & Naturopathy |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Application of katakabeeja churna and yoga techniques for the better management of Type 2 Diabetes Mellitus |
Scientific Title of Study
|
A Comparative Clinical Study To Evaluate The Efficacy Of
Katakabeeja Churna With Takra As Anupana And Selected Yoga
TECHNIQUES IN THE MANAGEMENT OF PRAMEHA (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 Navaneetha R |
Designation |
PG Scholar |
Affiliation |
Government Ayurveda Medical College, Mysore |
Address |
Government Ayurveda Medical College, Mysore
Mysore KARNATAKA 570001 India |
Phone |
8828293727 |
Fax |
|
Email |
navaniayu@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Venkatakrishna K V |
Designation |
Professor and Head Dept of PG studies in Swasthavritta in |
Affiliation |
Government Ayurveda Medical College, Mysore |
Address |
Government Ayurveda Medical College, Mysore
Mysore KARNATAKA 570001 India |
Phone |
9448572614 |
Fax |
|
Email |
srisadguru@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Navaneetha R |
Designation |
PG Scholar |
Affiliation |
Government Ayurveda Medical College, Mysore |
Address |
Government Ayurveda Medical College, Mysore
Mysore KARNATAKA 570001 India |
Phone |
8828293727 |
Fax |
|
Email |
navaniayu@gmail.com |
|
Source of Monetary or Material Support
|
OPD and IPD of Government Ayurveda medical College, Mysore |
|
Primary Sponsor
|
Name |
Dr Navaneetha R |
Address |
Government Ayurveda Medical College and Hospital, Mysore |
Type of Sponsor |
Other [self] |
|
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 Navaneetha R |
Government Ayurveda Medical College and Hospital, Mysore |
Room no 12, ground floor , near Visvesvaraya circle ,Dept of Swasthavritta,Government Ayurveda Medical College and Hospital, Mysore
Mysore KARNATAKA |
8828293727
navaniayu@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
GAMC Mysore Ethical committee |
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: PRAMEHAH, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
1 - Kataka beeja Churna
2 - Selected Yoga Techniques |
1 - Kataka beeja Churna with Takra as Anupana for 30 days
Shithileekarana vyayama 10 Minutes
Surya namaskara 4 cycles
Ardha kati chakrasana 4 cycles
Parivarta trikonasana 4 cycles
Vakrasana 4 cycles
Pashchimothasana 4 cycles
Pavanamukthasana 4 cycles
Shavasana 2 Minutes
PRANAYAMAS:
Pranayama Duration
Nadishudhi pranayama 10 cycles
Kapalabhati 5 cycles
Ujjayi pranayama 5 cycles
Bhastrika pranayama 5 cycles
Deep breathing 1Minute
total Duration of yoga techniques - 45 minutesper day
total days of interventiomn 30 days
|
Comparator Agent |
selected yoga techniques |
Shithileekarana vyayama 10 Minutes
Surya namaskara 4 cycles
Ardha kati chakrasana 4 cycles
Parivarta trikonasana 4 cycles
Vakrasana 4 cycles
Pashchimothasana 4 cycles
Pavanamukthasana 4 cycles
Shavasana 2 Minutes
PRANAYAMAS:
Pranayama Duration
Nadishudhi pranayama 10 cycles
Kapalabhati 5 cycles
Ujjayi pranayama 5 cycles
Bhastrika pranayama 5 cycles
Deep breathing 1Minute
total duration - 45 minutes per day
total days of intervention - 30 days |
|
Inclusion Criteria
|
Age From |
30.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
-Subjects of age group between 30-60 years fulfilling the diagnostic criteria will be selected for the study
-Recently diagnosed ( within 5 years) subjects with FBS level from 126mg/dl- 170 mg/dl and PPBS
level from 181-230 mg/dl
|
|
ExclusionCriteria |
Details |
- Diagnosed case of Diabetes with established features of neuropathy and retinopathy
- Type 1 Diabetes mellitus
- Pregnant/ lactating women
- Subjects taking anti diabetic medicines.
- Known cases of chronic systemic illness
- Known cases of uncontrollable hypertension
- Subjects on Steroids and oral contraceptives.
- Subjects unfit for yoga techniques.
|
|
Method of Generating Random Sequence
|
Other |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Reduce the symptoms such as • Pipaasadhikyata( Excessive thirst)
• Prabhoota aavila mutrata (Excessive and turbid urination)
• Kshutaadhikyata (Excessive hunger)•
•
|
30 Days |
|
Secondary Outcome
|
Outcome |
TimePoints |
Reduce blood sugar level into Normal |
30 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)
|
10/08/2021 |
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
|
Prameha
is a disease well known since Vedic period. It is one of the Ashta mahagada1 and also
considered as Agrya among Anushangi vikaras2 .Prameha has been described as chirakalina vyadhi in which Tridosha vriddhi with special involvement of kapha and kleda are seen,
with the cardinal feature of Prabhutha
avila mutrata3 .The further progression of Prameha may affect
all the 10 Dushyas and leads to upadrava4.
Type
2 Diabetes mellitus can be correlated to prameha in Ayurveda classics, which is
characterized by reduced sensitivity to the action of Insulin and inability to
produce sufficient insulin to overcome the insulin resistance.5 It
is the most common type of diabetes worldwide, and develops commonly in
people above 40 years. Worryingly, complications are usually common in
individuals with Type 2 Diabetes mellitus ,when it’s left untreated in the
early stages.
According
to current statistics Diabetes mellitus affects about 69.1 million Indians
which comprises 8.9% of the Indian adult populations6. Type 2
diabetes accounts for about 4.6 million deaths worldwide every year and is
projected by WHO to be the 7th leading causes of death by 20307.So,
this is an alarming situation demanding an effective management in Type 2
Diabetes mellitus.
Though many research works are conducted on prameha, scientists are struggling to
search an effective and harmless remedy. It has always been treated by oral
hypoglycemic agents and insulin, but they all have adverse effects and
unaffordable as well. Therefore, from the patients perceptive, minimizing the
burden imposed by type 2 Diabetes mellitus requires an approach that ensures
service which is accessible and affordable.
kataka beeja (seed of strychnos potatorum Linn.) is one of the drug which is
easily available and affordable, having Kapha
medhohara property, and it is specifically indicated in Prameha with Takra as Anupana8
The
ease of use, safety and multiple health benefits of yoga have led to be more
widely accepted by the society and considered as low cost intervention to
control lifestyle disorders includes Diabetes. Recent Studies shows that
Performing the specific yogaasanas explained
in Prameha result in the regeneration
of pancreatic cells and helps to improve the sensitivity of Beta cells to
glucose thereby improving the insulin secretion .While pranayamas
indicated for Prameha are useful in slowdown the mind, thereby reduces
stress level and helps to lower blood
sugar levels9.
The
current study aims to explore a new, safe, effective and cheaper management
base for Type 2 Diabetes mellitus and this would be significally address
burning issues of Diabetes in society.
In
this regard, to evaluate the individual & comparative efficacy of katakabeeja churna with takra as Anupana & yogic techniques in the management of Prameha (Type 2 Diabetes mellitus) is
undertaken for study. |