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CTRI Number  CTRI/2024/12/078383 [Registered on: 20/12/2024] Trial Registered Prospectively
Last Modified On: 14/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To assess the role of Lekhana Basti in Sthoulya (Obesity) 
Scientific Title of Study   Comparative Clinical Evaluation of Ushakadi Gana Lekhana Basti and Asanadi Gana Lekhana Basti in Sthoulya (Obesity) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Arvind Gupta  
Designation  Professor  
Affiliation  Himalayiya Ayurvedic PG Medical College and Hospital  
Address  OPD NO 11, Department of Panchakarma, Himalayiya Ayurvedic PG Medical College and Hospital, Fatehpur Tanda, Majri grant via Doiwala, Dehradun

Dehradun
UTTARANCHAL
248140
India 
Phone  7895624474  
Fax    
Email  arvindguptapk@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ramniwas Dhayal  
Designation  PG Scholar  
Affiliation  Himalayiya Ayurvedic PG Medical College and Hospital  
Address  OPD NO 11, Department of Panchakarma, Himalayiya Ayurvedic PG Medical College and Hospital, Fatehpur Tanda, Majri grant via Doiwala, Dehradun

Dehradun
UTTARANCHAL
248140
India 
Phone  8947049394  
Fax    
Email  drram468@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ramniwas Dhayal  
Designation  PG Scholar  
Affiliation  Himalayiya Ayurvedic PG Medical College and Hospital  
Address  OPD NO 11, Department of Panchakarma, Himalayiya Ayurvedic PG Medical College and Hospital, Fatehpur Tanda, Majri grant via Doiwala, Dehradun

Dehradun
UTTARANCHAL
248140
India 
Phone  8947049394  
Fax    
Email  drram468@gmail.com  
 
Source of Monetary or Material Support  
Himalayiya Ayurvedic PG Medical College and Hospital, Fatehpur Tanda, Majri grant via Doiwala Dehradun Uttranchal  
 
Primary Sponsor  
Name  Dr Ramniwas Dhayal  
Address  PG Department of Panchakarma, Himalayiya Ayurvedic PG Medical College and Hospital, Fatehpur Tanda, Majri grant via Doiwala Dehradun  
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 Ramniwas Dhayal   Himalayiya Ayurvedic PG Medical College and Hospital   OPD NO 11, Department of Panchakarma, Himalayiya Ayurvedic PG Medical College and Hospital, Fatehpur Tanda, Majri grant via Doiwala, Dehradun
Dehradun
UTTARANCHAL 		 8947049394

drram468@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Minutes of Institutional Ethical 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: STHULARUSHKA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Astanga H.Su.-15/19-20, Procedure details: The complete Lekhana Basti procedure will include Asanadi Gana Lekhana Basti in the morning for 15 days along with Matra Basti (48 ml) in the evening.))
(1) Medicine Name: Asanadi Gana Lekhana Basti , Reference: Astanga H.Su.-15/19-20, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 576(ml), Frequency: od, Duration: 15 Days
2Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Astanga H.Su.-15/23, Procedure details: The complete Lekhana Basti procedure will include Ushakadi Gana Lekhana Basti in the morning for 15 days along with Matra Basti (48 ml) in the evening.))
(1) Medicine Name: Ushakadi Gana Lekhana Basti , Reference: Astanga H.Su.-15/23, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 576(ml), Frequency: od, Duration: 15 Days
3Comparator ArmDrugClassical(1) Medicine Name: Asanadi Gana dravya , Reference: Astanga H.Su.-15/19-20, Route: Rectal, Dosage Form: Kalka/ Paste , Dose: 48(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: -
4Intervention ArmDrugClassical(1) Medicine Name: Ushakadi Gana dravya , Reference: Astanga H.Su.- 15/23, Route: Rectal, Dosage Form: Kalka/ Paste , Dose: 48(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Patients having cardinal sign and symptoms of Sthoulya.
2.Patients between age group of 16 to 70 years suffering from Sthoulya.
3.Patients BMI of 25 to 40 kg/m²
4.patients fit for Basti Karma. 
 
ExclusionCriteria 
Details  1.Patients having age below 16 years and more than 70 years.
2.Patients associated with chronic illness like cardiac disease, Renal, Hepatic disease, Thyroid, HTN, DM.
3.Patients unfit for Basti Karma.
4.Pregnant and lactating mothers  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Relief in Signs and Symptoms (Atikshudha, Atinidra. Pipasha Adhikya. Sweda Adhikya, Kshudra Shwaas, Gaurav, Daurbalya, Alasya )   4 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
Normal BMI Level   8 weeks  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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/ Phase 3 
Date of First Enrollment (India)   26/12/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Obesity is the excessive or abnormal accumulation of fat or adipose tissue in the body. Overweight and obesity are two main consequences of many chronic diseases. Obesity is measured by the body mass index (BMI) which is a simple index that is commonly used to classify overweight and obesity in adults. According to WHO Overweight BMI is 25-29.9 and Obesity BMI is greater than or equal to 30 in adults. The prevalence of overweight and obesity are 23.45% In India obesity and overweight has reached epidemic proportions affecting 5% of countries population and worldwide 35.8 million (2.3%). In Ayurveda obesity can be compared with Sthoulya According to Acharya Charaka Sthoulya as the excessive increase of Meda and Mamsa Dhatu cause pendulous movement of abdomen, buttocks and breast. The aetiological factors mainly vitiate Kapha dosha and Meda Dhatu and Vata gets Avrita by excessive Meda. Thus if Apatarpaka Dravyas are used alone, it increases the vitiated Vata. Hence treatment should be planned considering vitiated Vata, Meda and Kapha. Hence its management will be planned with Lekhana Basti Acharya Charaka has mentioned Lekhana Basti in the management of Santrpanajaya Vyadhi and in Bahudosha avastha condition. Lekhniya Dravya is the substance that removed the increased Dhati, Rasa & Meda by scraping or scratching.In this study we evaluate the efficacy of Ushakadi Gana Lekhana Basti and Asanadi Gana Lekhana Basti in the management of Sthoulya. 
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