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CTRI Number  CTRI/2022/05/042784 [Registered on: 24/05/2022] Trial Registered Prospectively
Last Modified On: 22/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Kshar Takra Basti and Ruksha Udvartana by Triphala churna in Obesity (Sthoulya) 
Scientific Title of Study   A comparative clinical study to evaluate the efficacy of kshar takra basti and ruksha udvartana by triphala churna in the management of sthoulya with special reference to obesity 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vinita Chandrakar 
Designation  PG Scholar 
Affiliation  National Institute of Ayurveda 
Address  Room Number 111 PG seminar hall P.G. Department of Panchkarma National Institute of Ayurveda Jaipur, Rajasthan 302002 India
Madhav vilas palace Zorawar singh Gate amer road jaipur
Jaipur
RAJASTHAN
302002
India 
Phone  9406303879  
Fax    
Email  cvinita02@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Surendra Vedpathak 
Designation  HOD Department of Panchakarma  
Affiliation  National Institute of Ayurveda 
Address  Room 114 new Panchakarma building, Panchakarma department, national institute of ayurveda
Madhav vilas palace, amer road, zorawar singh gate, jaipur
Jaipur
RAJASTHAN
302002
India 
Phone  7030309088  
Fax    
Email  drsurendravedpathak50@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vinita Chandrakar 
Designation  PG Scholar 
Affiliation  National Institute of Ayurveda 
Address  Room Number 111 PG seminar hall P.G. Department of Panchkarma National Institute of Ayurveda Jaipur, Rajasthan 302002 India
Madhav vilas palace Zorawar singh Gate amer road jaipur
Jaipur
RAJASTHAN
302002
India 
Phone  9406303879  
Fax    
Email  cvinita02@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda 
 
Primary Sponsor  
Name  National Institute of Ayurveda Deemed to be University 
Address  Amer road near jorawar singh gate jaipur Rajasthan 
Type of Sponsor  Research institution and hospital 
 
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 Vinita Chandrakar  National Institute of Ayurveda Deemed to be University  panchkarma OPD number 2, hospital building, NIA campus, zorawar Singh gate, amer road Jaipur
Jaipur
RAJASTHAN 		 9406303879

cvinita02@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E669||Obesity, unspecified,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Charak sootrasthana 21/21-24, Procedure details: Kshar Takra Basti via Anal route, on empty stomach (will be given according to Kala – Basti pattern as per classical method).There will be 06 Niruha Basti with 10 Anuvasana, 01 Anuvasana will be administer first day then each on alternate day and remaining 03 Anuvasana Basti at last. The total duration of therapy will be for 16 days)
2Comparator ArmProcedure-udvartanam, उद्वर्तनम् (Procedure Reference: Sushrut sootra 24/51, Procedure details: Ruksha Udvartana with Triphala Churna (250gm)for 30- 45 minutes, each day in morning, till-16 days, empty stomach.)
(1) Medicine Name: Tripahala , Reference: Ashtanga hridayak sootra 6/159, Route: Topical, Dosage Form: Churna/ Powder, Dose: 250(g), Frequency: od, Duration: 16 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patient suffering from classical sign and symptoms of Sthoulya.(Atikshudha, Atipipasa, Daurgandhya, Nidhradhikya)
2.The patient aged between 18 to 60 years of either sex.
3.Patient willing and able to participate in this study for entire trial period.
4.BMI criteria for the selection of the patient. (Over weight, obesity-1 and 2)
5.Patient fits for Basti karma and Udvartana karma.
 
 
ExclusionCriteria 
Details  1.Patients with hypothyroidism
2.Patients with long term steroid treatment.
3.Patients with severe hypertension.
4.Patients with evidence of renal, hepatic and cardiac involvement.
5.Patients with skin related problem like- itching, burn, rashes etc.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Change in Weight.
2.Relief in symptoms like - Atikshuda,Alasya, Atipipasa, Nidraadhikya, Daurgandhya etc.
 		 16 days with one month follow-up
 
 
Secondary Outcome  
Outcome  TimePoints 
1.Change in Waist circumference, MAC, Skinfold Thickness.
2.Change in Morbidity score.
 		 16 days with one month follow-up 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   20/06/2022 
Date of Study Completion (India) 30/04/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Sthoulya is one among the most burning problem of our society because this age of machine and materialism. In our routine life physical activities are reduced and mental stress is increased. Lack of physical activities with increased intake of food, industrialization, stress during the work, various variety of the junk food eg- fast food, frozen food, bakery items, increased amount of soft drinks results in Sthoulya.  Obesity is characterized to excessive accumulation of fat. In recent year urban youth are particularly prone to the life style diseases. In Ayurveda, the description about Sthoulya is available in many Samhitas  various Samhitas as Sthoulya or Medoroga in Santarpanottha vikara i.e. the disease caused by overnourishment. In Charak Samhita this condition is described under the heading of Santarpanajanya vyadhi. Acharya Yoga Ratnakara and Vangsen explained under the heading of Medoroga. Acharya Chakrapani and Bhavprakash described about Sthoulya.

Obesity is a leading preventable cause of death worldwide, with increasing prevelance in adults and children, and authorities view it as one of the serious public health problem of the 21st century. There is the need of the time to look into the alternative systems for the management. Therefore, with these perspectives the present trial entitled “ A comparative clinical study to evaluate the efficacy of Kshar Takra Basti and Ruksha Udvartana in the management of Sthoulya w.s.r. to obesity” has been planned.  

Aim :To compare the efficacy of Kshar Takra Basti and Ruksha Udvaratana by Triphala churna in the management of Sthoulya w.s.r. to obesity.

Objective: 1. To restore normal development and to reduction the sign and symptom of Sthoulya.

2.To provide effective, safe and economic remedy for adult in Sthoulya.

3. To identify a safe and effective Ayurveda Treatment for Sthoulya with minimum or no recurrence.

RESEARCH QUESTION:-

Is there any diffrences between the efficacy of Kshar Takra Basti and Ruksh Udvartan By Triphla churna in Sthoulya with special reference to Obesity.

HYPOTHESIS: -

Null Hypothesis ( H0 )  -There is no diffirence in the efficacy of  Kshar Takra Basti and Ruksha Udvartana by a Triphala churna in the management of Sthoulya with special reference to obesity.

Alternative Hypothesis - 

H1 - Kshar Takra Basti has significant effect in Sthoulya with special reference to obesity.

H2 - Ruksha Udvartana has significant effect in Sthoulya with special reference to obesity.

LABORATORY INVESTIGATION (Before Treatment and after Treatment) : -

Ø    CBC,

Ø    Urine, Stool Examination

Ø    Lipid Profile

 
 
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