EFFECT OF AYURVEDIC TREATMENT ON OBESE PATIENTS
- Conditions
- Obesity due to excess calories,
- Registration Number
- CTRI/2020/06/026219
- Lead Sponsor
- DR NILESH SUBHASH KULTHE
- Brief Summary
OBESITY IS ONE OF THE ROOT CAUSE FOR DISEASES LIKE DIABETES MELLITUS, HYPERTENSION. ISCHEMIC HEART DISEASE.
CONSIDERING THE MOTIVE OF NATIONAL HEALTH POLICY, INORDER TO BRING IN REDUCTION IN NUMBER OF CASES OF DIABETES MELLITUS, HYPERTENSION. ISCHEMIC HEART DISEASE, THIS STUDY ON OBESITY IS PLANNED.
**TITLE** AS
RANDOMISED CLINICAL TRIAL TO EVALUATE THE EFFECT OF OBESITY MANAGEMENT REGIMEN IN OBESITY
Needto work on obesity as one the major leading cause for cardiac ailments andmetabolic disease like diabetes mellitus, hypertension. India world’s 3rdmost obese after U.S., China. NATIONAL HEALTH POLICY focuses on Non communicablediseases like Cardiovascular Disease along with Diabetes, Hypertension
- **OBJECTIVES**
**Primary objective:**
To evaluate the effect of obesity managementregimen in reducing weight in obesity
**Secondaryobjectives**:
i) To evaluate the effect of obesity managementregimen on Body Mass Index in obesity
ii) To evaluate the efficacy ofobesity management regimen on Abdominal girth.
240 patients will be considered in study
· **Criteria for Inclusion:**
1) Allsubjects of either gender between age twentyto sixty years.
2) Alldiagnosed with obesity criteria i.e Body Mass Index more than 25.
- **Criteria for Exclusion:**
1. Having and prediagnosed for T.B, I.H.D,hypothyroidism, Cushing’s syndrome, HIV.
2. Any concomitant serious disorders of Liver,Kidney, Heart, Lungs.
- **Criteria for Withdrawal:**
Any Subject, who develops reaction, will be treatedaccordingly and withdrawal will be done from study.
**.Methods of measurements:**digital weighining scale, digital meter tape
**IX.Study instrument / Data collection tool:** Caserecord Form
**X.Methods of data collection:**
- **Primary Data:** Primary data will be collected from patients by using Case Record Form.
- **Secondary Data:** It collected form Text Books, Classical books, reference books, journals, database, and websites.
- **Methods of Data collection relevant to objective:** Data will be collected with the help of history taking, physical examinations.
**XI.Data management and analysis procedure**
Collecteddata will be presented in the form of tables and charts.
**XII.Data analysis plan and methods**
Data analysis for subjective parameters will be done by Wilcoxon signed ranktest and for objective parameters Paired t test (modified) will be applied at 5 % levelofsignificancein all symptoms which will be critically evaluated at the end of study.
- **FORMULATION DETAILS: basti will be prepared with Above contents KNG *kadha*= (***Kulith* 10%, *Nagvelpatra* 10%, *Gudmar* 5%)
**1.)** **BASTIDURATION-** 960 ml basti(Niruha) will be given once a week for three months**.**
**2.) Diet-**Specially designed dietas 40%: Fat, 25%: Protein and 35%: Carbohydrates will be advised
**3.)Yoga*:*** *Pawanmuktasan, Bhujangasan, Trikonasa* each for 7 times + Daily brisk walk 30 mins
· **TREATMENT DETAILS:**
**TrialGroup:** single group
**Durationof Intervention**: 3months
**Followup**: every 15 days
**TotalDuration of Study**: Three years
**AssessmentCriteria:**
**1.)****Shwas(**Difficuilty in breathing**)**
Absent 0
On unaccustomedwork 1
On accustomedwork 2
Even at rest 3
2.) **Angagaurav(**Heaviness of body)
Absence of gaurava 0
Ocassional Heaviness 1
Persistant heaviness relieved afterrest 2
Persistant heaviness not relieved by restbut 3
can do normal daily work
Persistant heaviness cannot do normal dailywork 4
**3.)****Swedadhikya (**excessivesweating**)**
Sweatingafter heavy work 0
Sweating after little work 1
Profuse Sweating after Heavy work 2
Profuse Sweating after minimum work 3
Sweating even in resting condition 4
**4.)** **Atiksuda (**polyphagia**)**
Unwilling to take food butcould take the meal 0
Willing towards most likingfood and not others 1
Willing toward only one amongkatu/amla/lavana/
Madhura food stuff 2
Willing towards somespecific Ahara/rasa/Vishesha 3
Equal willing towards allbhojya Padarhta 4
**5.)** **Daurbalya (**weakness**)**
Can doroutine exercise 0
Can do moderate exercisewithout difficuilty 1
Can do only mildexercise 2
Can do mild exercise withvery Difficuilty 3
Cannot do mild exercise 4
**6.)** **Atipipasa (**Polydipsia**)**
Normalthirst 0
Upto 1 L excess of waterintake 1
1 to 2 L excess of waterintake 2
2 to 3 L excess of waterintake 3
More than 3 L excess of water intake 4
**ObjectiveAssessment criteria:**
**7.)****BodyMass Index**
**8.)****Waistcircumference**
**Laboratory Investigations:** Before andafter treatment
1. Lipid Profile
- **DISCUSSION**
Discussionwill be done after studies regarding efficacy of Obesity management regimen
- **CONCLUSION**
Conclusionwill be done after completion of studies.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 240
SUBJECTS OF EITHER GENDER AGE 20 YRS TO 60 YRS BODY MASS INDEX MORE THAN 25.
- Having and prediagnosed for T.B, I.H.D, hypothyroidism, Cushing’s syndrome, HIV.
- Any concomitant serious disorders of Liver, Kidney, Heart, Lungs.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method BODY MASS INDEX REDUCTION 90DAYS
- Secondary Outcome Measures
Name Time Method WEIGHT REDUCTION 30 DAYS
Trial Locations
- Locations (1)
YASHWANT AYURVED COLLEGE KODOLI KOLHAPUR
🇮🇳Kolhapur, MAHARASHTRA, India
YASHWANT AYURVED COLLEGE KODOLI KOLHAPUR🇮🇳Kolhapur, MAHARASHTRA, IndiaDR SURYAKIRAN WAGHPrincipal investigator09822846910suryakiranwagh@gmail.com