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CTRI Number  CTRI/2020/06/026219 [Registered on: 29/06/2020] Trial Registered Prospectively
Last Modified On: 27/06/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   EFFECT OF AYURVEDIC TREATMENT ON OBESE PATIENTS 
Scientific Title of Study   RANDOMISED CLINICAL TRIAL TO EVALUATE THE EFFECT OF OBESITY MANAGEMENT REGIMEN IN OBESITY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  NILESH SUBHASH KULTHE 
Designation  PHD SCHOLAR 
Affiliation  YASHWANT AYURVED COLLEGE PHD CENTRE KODOLI, KOLHAPUR 
Address  A/P KODOLI, TAL- PANHALA DISTRICT - KOLHAPUR- 416114

Kolhapur
MAHARASHTRA
416114
India 
Phone  8087271812  
Fax    
Email  drnilkul@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR SURYAKIRAN P WAGH 
Designation  H.O.D, PROFESSOR 
Affiliation  YASHWANT AYURVED COLLEGE PHD CENTRE, KODOLI, KOLHAPUR 
Address  A/P KODOLI, TAL- PANHALA DISTRICT - KOLHAPUR 416114

Kolhapur
MAHARASHTRA
416114
India 
Phone  9822846910  
Fax    
Email  suryakiranwagh@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR SURYAKIRAN P WAGH 
Designation  H.O.D, PROFESSOR 
Affiliation  YASHWANT AYURVED COLLEGE PHD CENTRE, KODOLI, KOLHAPUR 
Address  A/P KODOLI, TAL- PANHALA DISTRICT - KOLHAPUR 416114

Kolhapur
MAHARASHTRA
416114
India 
Phone  9822846910  
Fax    
Email  suryakiranwagh@gmail.com  
 
Source of Monetary or Material Support  
YASHWANT AYURVED COLLEGE, KODOLI, KOLHAPUR 
 
Primary Sponsor  
Name  DR NILESH SUBHASH KULTHE 
Address  YASHWANT AYURVED COLLEGE PHD CENTRE KODOLI KOLHAPUR 
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 SURYAKIRAN WAGH  YASHWANT AYURVED COLLEGE KODOLI KOLHAPUR  KAYACHIKITSA DEPT 2nd FLOOR, MAIN BUILDING A/P-KODOLI, TAL- PANHALA, DIST- KOLHAPUR 416114
Kolhapur
MAHARASHTRA 		 09822846910

suryakiranwagh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
YASHWANT AYURVED COLLEGE ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E660||Obesity due to excess calories,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
Intervention  obesity regimen  Calorie restricted diet over a day (ghavan mix 40gm 133calories, daliya upma 40 gm 120 calories, kulith idli 40 gm 120 calories, lean atta 25 gm 22 calories, panchavti dal 30 gm 85 calories, pro fiber mix 10 gm 36 calories, supernuts 15 gm 100 calories, carrot soup 20 gm 32 calories, chutney mix 10 gm 65 calories, green tea 1 sachet, 39 calories + Yogasanas- (Pawanmuktasana, Bhujangasana, Trikonasana) 30 mins daily+ per rectal administration of drug once a week for 3 months 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  SUBJECTS OF EITHER GENDER
AGE 20 YRS TO 60 YRS
BODY MASS INDEX MORE THAN 25 
 
ExclusionCriteria 
Details  Having and prediagnosed for T.B, I.H.D, hypothyroidism, Cushing’s syndrome, HIV.

Any concomitant serious disorders of Liver, Kidney, Heart, Lungs
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
BODY MASS INDEX REDUCTION
 		 90DAYS 
 
Secondary Outcome  
Outcome  TimePoints 
WEIGHT REDUCTION  30 DAYS 
 
Target Sample Size   Total Sample Size="240"
Sample Size from India="240" 
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 
Date of First Enrollment (India)   29/06/2020 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   RESEARCH PAPER WILL BE PUBLISHED 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

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

Need to work on obesity as one the major leading cause for cardiac ailments and metabolic disease like diabetes mellitus, hypertension. India world’s 3rd most obese after U.S., China. NATIONAL HEALTH POLICY focuses on Non communicable diseases like Cardiovascular Disease along with Diabetes, Hypertension

  • OBJECTIVES

Primary objective:

To evaluate the effect of obesity management regimen in reducing weight in obesity   

Secondary objectives:

i)                    To evaluate the effect of obesity management regimen on Body Mass Index in obesity 

ii)                  To evaluate the efficacy of obesity management regimen on Abdominal girth.

240 patients will be considered in study

·                Criteria for Inclusion:

1)      All subjects of either gender between age twenty to sixty years.

2)      All diagnosed 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 treated accordingly and withdrawal will be done from study.


. Methods of measurements:  digital weighining scale, digital meter tape

IX. Study instrument / Data collection tool: Case record 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

Collected data 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 rank test and for objective parameters Paired t test (modified) will be applied at 5 % level of significance in 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.)    BASTI DURATION- 960 ml basti (Niruha) will be given once a week for three months.

2.) Diet- Specially designed diet as 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:

Trial Group: single group

Duration of Intervention:  3 months

Follow up: every 15 days

Total Duration of Study: Three years

Assessment Criteria:

 

1.)                Shwas (Difficuilty in breathing)

 

    Absent                                                                                                                                 0

    On unaccustomed work                                                                                                      1

    On accustomed work                                                                                                          2

    Even at rest                                                                                                                         3

           

2.)                Angagaurav (Heaviness of body)

   Absence of gaurava                                                                                                                         0

   Ocassional Heaviness                                                                                                                      1

   Persistant heaviness relieved after rest                                                                                            2

   Persistant heaviness not relieved by rest but                                                                                   3

   can do normal daily work

   Persistant heaviness cannot do normal daily work                                                                           4

 

3.)                 Swedadhikya (excessive sweating)

    Sweating after 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 but could take the meal                                                                             0

    Willing towards most liking food and not others                                                                           1

    Willing toward only one among katu/amla/lavana/        

    Madhura food stuff                                                                                                                        2

    Willing towards some specific Ahara/rasa/Vishesha                                                                     3

    Equal willing towards all bhojya Padarhta                                                                                     4

 

5.) Daurbalya (weakness)

    Can do routine exercise                                                                                                                0

    Can do moderate exercise without difficuilty                                                                                 1

    Can do only mild exercise                                                                                                              2

    Can do mild exercise with very Difficuilty                                                                                       3

    Cannot do mild exercise                                                                                                                 4

 

6.) Atipipasa (Polydipsia)

   Normal thirst                                                                                                                       0

   Upto 1 L excess of water intake                                                                                          1

   1 to 2 L excess of water intake                                                                                            2

   2 to 3 L excess of water intake                                                                                            3

   More than 3 L excess of water intake                                                                                 4            

Objective Assessment criteria:

7.)                Body Mass Index

 

 

8.)                Waist circumference

 

 

  Laboratory Investigations: Before and after treatment

           1. Lipid Profile

  • DISCUSSION

Discussion will be done after studies regarding efficacy of Obesity management regimen

  • CONCLUSION

Conclusion will be done after completion of studies.


 
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