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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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