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CTRI Number  CTRI/2021/02/031262 [Registered on: 12/02/2021] Trial Registered Prospectively
Last Modified On: 18/02/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Other (Specify) [ABDOMINAL BAND]  
Study Design  Other 
Public Title of Study   Abdominal band to reduce central obesity 
Scientific Title of Study   An open label double arm control clinical study to evaluate the add on effectiveness of shigruvaadi udara bandhana in central obesity  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  chaithra 
Designation  PG scholar Department of swasthavritta 
Affiliation  Sri Dharmasthala Manjunatheswara College of Ayurveda and hospital 
Address  Department of swasthavritta Sri Dharmasthala Manjunatheswara College of Ayurveda and hospital,BM Road Thanniruhalla , Hassan,Karnataka 573201
BM Road Thanniruhalla , Hassan,Karnataka 573201
Hassan
KARNATAKA
573201
India 
Phone  9740316888  
Fax    
Email  hnchaithra12@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Chaithra HN 
Designation  PG scholar Department of swasthavritta 
Affiliation  Sri Dharmasthala Manjunatheswara College of Ayurveda and hospital 
Address  Department of swasthavritta Sri Dharmasthala Manjunatheswara College of Ayurveda and hospital,BM Road Thanniruhalla , Hassan
BM Road Thanniruhalla , Hassan
Hassan
KARNATAKA
573201
India 
Phone  9740316888  
Fax    
Email  hnchaithra12@gmail.com  
 
Details of Contact Person
Public Query  
Name  Chaithra HN 
Designation  PG scholar Department of swasthavritta 
Affiliation  sri Dharmasthala Manjunatheswara College of Ayurveda and hospital 
Address  Department of swasthavritta Sri Dharmasthala Manjunatheswara College of Ayurveda and hospital,BM Road Thanniruhalla , Hassan
BM Road Thanniruhalla , Hassan
Hassan
KARNATAKA
573201
India 
Phone  9740316888  
Fax    
Email  hnchaithra12@gmail.com  
 
Source of Monetary or Material Support  
Department of swasthavritta Sri Dharmasthala Manjunatheswara College of Ayurveda and hospital,BM Road Thanniruhalla , Hassan 
 
Primary Sponsor  
Name  Sri Dharmasthala Manjunatheswara College of Ayurveda and hospital 
Address  Department of swasthavritta Sri Dharmasthala Manjunatheswara College of Ayurveda and hospital,BM Road Thanniruhalla , Hassan 
Type of Sponsor  Private medical college 
 
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 Tapas Brata Tripathy  Sri Dharmasthala Manjunatheswara College of Ayurveda and hospital  Department of swasthavritta Sri Dharmasthala Manjunatheswara College of Ayurveda and hospital,BM Road Thanniruhalla , Hassan
Hassan
KARNATAKA 		 9448705599

tbtripathy@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA & HOSPITAL,HASSAN  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: MEDOROGAH,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Abdominal band  Abdominal band 4 hours once in a day external application for 7 days 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  2. Waist circumference>40 inches (102 cm) in men and >35 inches (88 cm) in
women.
3. Waist height ratio >0.9 in males and>0.85 in females. 
 
ExclusionCriteria 
Details  1. Visible wounds over the abdomen and lower back.
2. Pregnant and post-partum woman.
3. Inflammatory skin conditions over the abdomen and lower back.
4. Known case of abnormal abdominal enlargements.
5. Known case of any organomegaly 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To reduce central obesity  Baseline third day seventh day 
 
Secondary Outcome  
Outcome  TimePoints 
To reduce bmi  Baseline third day seventh day 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "44"
Final Enrollment numbers achieved (India)="44" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/02/2021 
Date of Study Completion (India) 14/01/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 1. An Open label double armed clinical control study to evaluate the add on effectiveness of shigruvadi udara bhandana in central obesity 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 03-03-2022 and end date provided 04-03-2027?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   NAME OF HE DEPARTMENT- DEPARTMENT OF SWASTHAVRITTA NAME OF THE STUDENT-Dr. Chaithra HN NAME OF THE GUIDE- Dr. Tapas Brat Tripathy TITLE OF THE STUDY- “An open label double arm control clinical study to evaluate the add on effectiveness of shigruvaadi udara bandhana in central obesity” SUMMARYObesity is the major health challenge in the present era, mainly caused due to improper way of living and food habits. Central obesity is one of the types of obesity having excess accumulation of fat in the abdominal area with higher health risks. Thus, this study is intended to reduce abdominal obesity using shigruvaadi swedopaga udara bandhana. OBJECTIVESTo evaluate the add on effectiveness of shigruvaadi udara bandhana in central obesity METHODOLOGYMETHODOLOGY-interventional clinical study Research design- An open label double arm control clinical study conducted for 7 days: having 40 participants and 20 participants each are divided among two groups. Group 1(N=20) patients will be given udvartana with udvartana churna- 30 min. Group 2(N=20) patients will be given udvartana with udvartana churna -30 min and udara bandhana-4 hours. Source of data: 40 patients fulfilling the diagnostic criteria and inclusion criteria will be selected from out-patient and in-patient department of swasthavritta and yoga, Sri Dharmasthala college of Ayurveda and hospital. INTERVENTION: For udara bandhana; the drugs -shigru, Yava, tila, Kulatta, masha (drugs mentioned under swedopaga dashemani by Charaka) are made into fine powder, made into lepa and applied over the abdomen about 2 cm thick when it is luke warm in temperature. It is covered by the cotton cloth. Using the other cotton cloth, the abdomen area is tied and left for 4 hours. Later asked to wash with warm water. RESEARCH DESIGNIn the present study 30 patients fulfilling the criteria for inclusion will be selected with convenience sampling technique. The selected patients will be open label single arm interventional study. SAMPLING TECHNIQUE: Convenient sampling method SAMPLE SIZE: 40 participants and 20 participants each are divided among two groups. conducted for 7 days. Diagnostic criteria: • Waist circumference>.40 inches (102 cm) in males and >35 inches (88 cm) in female • Waist height ratio >0.9 in males and>0.85 in females.14 ASSESSMENT CRITERIA Primary assessment: • Waist circumference • Waist height ratio • Abdominal girth • Skin fold thickness Secondary assessment • BMI FOLLOW UP DURING TREATMENT: Patients will be assessed on 3rd and 7th day during the study period. INCLUSION CRITERIA: 1. Age:25-60 yrs. 2. Waist circumference>40 inches (102 cm) in men and >35 inches (88 cm) in women. 3. Waist height ratio >0.9 in males and>0.85 in females. EXCLUSION CRITERIA. 1. Visible wounds over the abdomen and lower back. 2. Pregnant and post-partum woman. 3. Inflammatory skin conditions over the abdomen and lower back. 4. Known case of abnormal abdominal enlargements. 5. Known case of any organomegaly. 
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