| CTRI Number |
CTRI/2024/04/065644 [Registered on: 15/04/2024] Trial Registered Prospectively |
| Last Modified On: |
31/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Check The Efficacy of Musta phanta with Suryanamaskara of Ashtanga vinyasa yoga and diet in Obesity |
|
Scientific Title of Study
|
A Comparative Clinical Study To Evaluate The Efficacy Of Diet,Musta Phanta and Surya Namaskara of Ashtanga Vinyasa Yoga On Lipid Profile In Atisthoulya [Class I Obesity]
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anusha S Raykar |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda Medical College and Hospital |
| Address |
Department of Swasthavritta and Yoga ,Government Ayurveda Medical College and Hospital, Visvesvaraya Circle,Devaraja Mohalla,Mandi mohalla ,Mysuru, Karnataka 570001
Mysore
KARNATAKA
570001
India |
| Phone |
9108319706 |
| Fax |
|
| Email |
anushasraykar1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Venkatakrishna K V |
| Designation |
Professor And HOD ,Department Of Swasthavritta And Yoga. |
| Affiliation |
Government Ayurveda Medical College and Hospital |
| Address |
Department of Swasthavritta and Yoga ,Government Ayurveda Medical College and Hospital, Visvesvaraya Circle,Devaraja Mohalla,Mandi mohalla ,Mysuru, Karnataka 570001
Mysore
KARNATAKA
570001
India |
| Phone |
9448572614 |
| Fax |
|
| Email |
srisadguru@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anusha S Raykar |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda Medical College and Hospital |
| Address |
Department of Swasthavritta and Yoga ,Government Ayurveda Medical College and Hospital, Visvesvaraya Circle,Devaraja Mohalla,Mandi mohalla ,Mysuru, Karnataka 570001
Mysore
KARNATAKA
570001
India |
| Phone |
9108319706 |
| Fax |
|
| Email |
anushasraykar1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda Medical College and Hospital, Visvesvaraya Circle, Devaraja Mohalla, Mandi Mohalla, Mysuru, Karnataka 570001 |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 Anusha S Raykar |
Government Ayurveda Medical College and Hospital, Mysuru. |
Room no- 12,Department of Swasthavritta
Mysore
KARNATAKA |
9108319706
anushasraykar1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-Government Ayurveda Medical College and Hospital, Mysuru |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E660||Obesity due to excess calories. Ayurveda Condition: MEDOVRUDDHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Yoga For 30 Days, Pathya/Apathya:yes, Pathya:Individual Diet Chart Will Be Given To The Subjects Based On Their BMI According TO ICMR Guidelines, Apathya:Potato, Wheat, Curd, Excessive salt , Sweets, Fried And Junk Foods | | 2 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:yes, Pathya:Individual Diet Chart Will Be Given To The Subjects Based On Their BMI According To The ICMR Guidelines, Apathya:Potato, Sugar, Excessive Salt, Fried Items,Junk Foods,Wheat. | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Musta phanta , Reference: charaka samhita sutrasthana 4th chapter, Route: Oral, Dosage Form: Phanta, Dose: 100(ml), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Subjects of either gender,aged between 18-50 years are included
subjects with BMI ranged between 30-34.99(Kilogramme per meter square) |
|
| ExclusionCriteria |
| Details |
Diagnosed cases of systemic diseases which interferes with the intervention like uncontrolled DM HTN IHD Thyroid dysfunction
Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of Diet Musta phanta and suryanamaskara of ashtanga vinyasa yoga in reducing the body weight by comparing the anthropometry measurements taken before and after the intervention. |
31st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Efficacy of Diet Musta phanta and suryanamaskara of ashtanga vinyasa yoga in relieving other associated symptoms of obesity like pipasa adhikya[excessive thirst] sweda adhikya [excessive sweating] kshudra shwasa[ difficulty breathing on exertion] alasya[laziness] gourava [heaviness] atinidra[excessive sleep] |
31st day |
|
|
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 3 |
|
Date of First Enrollment (India)
|
18/04/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Obesity is one of the world’s oldest metabolic disorder its complications have become a burning
issue in the society Increased prevalence of obesity is due to urbanization change in dietary habits
and sedentary lifestyle Obesity is considered as Atishoulya in Ayurveda it is one among the
Santarpanajanya vyadhi it is classified under Kaphaja-nanatmaja vyadhi Atisthoola purusha is
one among Ashtanindita purusha Atisthoulya is caused due to intake of atimadhura, guru sheeta ahara and avyayama leading to Dhatvagnimandya causing kapha avarana and medovruddhi characterised by symptoms like chalasphik udara sthana, ayatopachaya autsaha atikshudha atipipasa etc Obesity is defined as an abnormal growth of the adipose tissue due to enlargement of fat cell
size (hypertrophic obesity) or an increase in fat cell number (hyperplastic obesity) or a combination
of both. Obesity is characterised by elevated levels of triglycerides low HDL and increased small dense LDL As per WHO in 2016 more than 1.9 billion adults aged 8 years and older were overweight Of these over 650 million men and women were obese According to ICMR-INDIAB study 2015 prevalence rate of obesity varies from 11.8% to 31.3% respectively Stopping the growing obesity
epidemic is one of the 2025 Global Nutrition Targets (for children under 5 years ) and one of the
targets for NCD reduction (for adolescent and adults) In contemporary science management of
obesity is explained through lifestyle modifications diet therapy physical activity and
pharmacotherapy Diet plays a key role in weight management as well Musta is a drug having deepana and
pachana effect on the body helps in normalising the medo dhatvagni and it has lekhana effect on
medas It is included under Lekhaneeya gana Triptighna Dahaprashamana gana in Charaka
samhita Hence musta used in hot infusion form is effective in management of Atisthoulya Ashtanga Vinyasa Yoga is a technique developed by Tirumalai Krishnamacharya and
popularized by K Pattabhi Jois that focuses on connecting the breath with the body posture that
tends to be set at a faster pace It helps in weight loss fitness and improves flexibility Researches
show that practice of Vinyasa yoga reduces elevated lipid concentration Though wide spectrum of treatment modalities are available for obesity the prevalence of the
disease is still high Hence this study aims to assess the effect of Diet usage of musta phanta and
vinyasa yoga on lipid profile in obesity |