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CTRI Number  CTRI/2022/08/044768 [Registered on: 22/08/2022] Trial Registered Prospectively
Last Modified On: 13/08/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Lekhana Basti and Diet in obesity 
Scientific Title of Study   Comparative Clinical evaluation of Lekhana Basti and specific Ahara in Sthaulya(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 Pravesh Kumar Mukeriya 
Designation  Associate professor  
Affiliation  Rishikul campus haridwar, Uttarakhand Ayurved University 
Address  Department of panchkarma, Rishikul campus Haridwar,Uttarakhand Ayurved University, Harrawala

Hardwar
UTTARANCHAL
249401
India 
Phone  7417935825  
Fax    
Email  praveshk312@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pravesh Kumar Mukeriya 
Designation  Associate professor  
Affiliation  Rishikul campus haridwar, Uttarakhand Ayurved University 
Address  Department of panchkarma, Rishikul campus Haridwar,Uttarakhand Ayurved University, Harrawala

Hardwar
UTTARANCHAL
249401
India 
Phone  7417935825  
Fax    
Email  praveshk312@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Megha Bisht 
Designation  M.D scholar 
Affiliation  Rishikul Campus Haridwar 
Address  Department of panchkarma,Rishikul Campus Haridwar,Uttarakhand Ayurved University,Harrawala

Hardwar
UTTARANCHAL
249401
India 
Phone  08393005767  
Fax    
Email  meghabisht0112@gmail.com  
 
Source of Monetary or Material Support  
Rishikul Campus Haridwar Uttarakhand Ayurved University 
 
Primary Sponsor  
Name  Uttarakhand Ayurved University 
Address  Uttarakhand Ayurved University Harrawala Dehradun  
Type of Sponsor  Government 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 
Megha Bisht  OPD and IPD of Rishikul Campus   Department of Panchkarma,Room no 20
Hardwar
UTTARANCHAL 		 08393005767

meghabisht0112@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. Ayurveda Condition: MEDOROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: sushruta chiktsa 38/82, Procedure details: In morning Lekhana Basti will be given empty stomach and in evening Anuvasana Basti with Murchita Tila Taila will be given after meal continuously for 15 days. Gap of 15 days will be given and again same procedure will be followed for 15 days and then again gap of 15 days will be given. )
(1) Medicine Name: Makshika, Saindhava Lavana, Moorchita Til Taila, Shatpushpa Kalka, Triphala Kwatha, Gomutra, Yava Kshar, Ushak Mrtika,Kasisdwea,Tutha, Hingu, Shilajeeta , Reference: sushruta chikitsa 38/82, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 480(ml), Frequency: od, Duration: 30 Days
2Comparator ArmLifestyle--Dinacarya: , Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:yes, Pathya:Yava, yavaka, veduyava, jau,purana shali, shaymak, udyalak, kordusha, godhuma, mudga, kulatha, chanaka, motha, patola, marisha, palaka, karvelaka, katutumbi, torai, parvala, shigru, ushnaodak, takra, laja,madhu, satu, madhudaka, sarshapa taila, Tila taila, saindhava lavana, fruits, doubled toned milk,katu, tikta, kashaya rasa, Apathya:
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patient having sign and symptoms of Sthaulya.
2.Patients of age 20-60 years.
3.Patient willing to take part in Lekhana Basti.
4.Patient fit for Lekhana Basti.
5.Patients willing to follow diet chart in Sthaulya
6.Patient with BMI 25 or greater than 25

 
 
ExclusionCriteria 
Details  1.Patient having age less than 20 years and above 60 years
2.Patients having uncontrolled diabetes, uncontrolled hypothyroidism, hypertension and other life-threatening complications.
3.Pregnant and lactating females
4.Body Mass index of (BMI>40 kg/m2)
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
No improvement:0-25%
Mild improvement:26-50%
Moderate improvement:51-75%
Marked improvement: 76-100%  		 0,15th,30th, 45th, 60th day 
 
Secondary Outcome  
Outcome  TimePoints 
exacerbation in signs and symptoms  60th day 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   24/08/2022 
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="0"
Months="11"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Obesity is defined as excess of adipose tissue that impart health risk. It is associated with an increased risk of multiple health problems, including type 2 diabetes, dyslipidemia, obstructive sleep apnea, nonalcoholic fatty liver disease, degenerative joint disease, and some malignancies. Obesity is a complex, multifactorial, and largely preventable disease, affecting, along with overweight, over one- third of the world’s population today. Obesity in India has reached epidemic proportions in the 21st century with morbid obesity affecting 5% of the country’s population. The most widely used method to classify weight status and risk of disease is body mass index (BMI). In India Patient with BMI≥25kg/m2 is considered obese. Sthaulya is a Santarpana Janya Vikara caused due to consumption of Guru, Madhura, Sheeta, Snigadha Ahara, Avayayam, Avayavaya, Diwaswapna, Harshnitya, Achinta and Beeja Dosha. Acharya Sushruta has mentioned about Lekhana Basti in management of Sthaulya, Basti is main treatment of vitiated Vayu and Lekhniya Dravya will subside the elevated Kapha and Meda so Lekhana Basti is selected for the treatment of Sthaulya. Vadiya Lolimbraj has given a very important principle regarding Pathya and Apathya. Study has been conducted on various single Ahara Dravya like Yava, Kodrava etc. which was found effective in obesity. Combination of these various Ahara Dravya will be more helpful in management of obesity. 
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