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CTRI Number  CTRI/2025/06/089563 [Registered on: 25/06/2025] Trial Registered Prospectively
Last Modified On: 12/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   effect of haridradi basti in management of sthaulya  
Scientific Title of Study   Assessing the efficacy of haridradi basti in the management of sthaulya randomized controlled clinical trial 
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 Reshma Narendra Nale 
Designation  MD Panchakarma Scholar 
Affiliation  C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad 431011  
Address  OPD No. 15 C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011
OPD No. 15 PANCHAKARMA DEPARTMENT
Aurangabad
MAHARASHTRA
431011
India 
Phone  7888266593  
Fax    
Email  reshmanale2107@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Megha Raosaheb Survase 
Designation  Associate Professor 
Affiliation  C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad 431011 
Address  OPD No. 15 C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011
OPD No. 15 PANCHAKARMA DEPARTMENT
Aurangabad
MAHARASHTRA
431011
India 
Phone  8149888802  
Fax    
Email  drmegha26@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Reshma Narendra Nale 
Designation  MD Panchakarma Scholar 
Affiliation  C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad 431011 
Address  OPD No. 15 C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011
OPD No. 15 PANCHAKARMA DEPARTMENT
Aurangabad
MAHARASHTRA
431011
India 
Phone  7888266593  
Fax    
Email  reshmanale2107@gmail.com  
 
Source of Monetary or Material Support  
CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi, Aurangabad, Maharashtra, India-431011 
 
Primary Sponsor  
Name  CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi, Aurangabad  
Address  Panchakarma Department,CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi, Aurangabad 431011 
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 Reshma Nale   CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi, Aurangabad   OPD NO.15 OF Panchakarma Department
Aurangabad
MAHARASHTRA 
7888266593

reshmanale2107@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E663||Overweight. Ayurveda Condition: MEDOROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Charak samhita, Procedure details: Haridradi Basti of 960 ml quantity in alternating sequence (vyatyasat krama) for duration of 8 days)
2Comparator ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Sushruta sanhita , Procedure details: Triphala Basti of 480ml quantity in alternating sequence (vyatyasat krama) for duration of 8 days )
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Diagnosis of patient according sign and symptoms like Daurbalyam, Swedobadha, Kshudha atimatra, Daurgandhyam . Having BMI between 25.0 to 29.9 kg/m². Age between 18.0 to 60.0 years, irrespective of gender, irrespective of occupation and socio-economic status. 
 
ExclusionCriteria 
Details  If patient age less than 18.0 years and greater than 60.0 years .
Having BMI greater than and equal to 30.0 kg/m².
Pregnant and lactating mother.
Patient having uncontrollable DM, HTN, Anorectal disorder,Systemic disorder. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduce BMI in kg/m²
Reduce abdominal Girth  
Baseline 0th day, 8th day, 24th day  
 
Secondary Outcome  
Outcome  TimePoints 
Actively do day to day activity   Baseline 0th day, 8th day, 24th day 
 
Target Sample Size   Total Sample Size="92"
Sample Size from India="92" 
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)   06/07/2025 
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   Lifestyle is considered to be an important part of health, but in today’s sedentary lifestyles, lack of physical activities, stressful life, irregular diet, irregular sleeping pattern lead to different kind of lifestyle disorder. In today’s fast placed world Sthaulya has become a prevalent health issue affecting many due to lifestyle factors.
Charaka samhita also described eight kinds of men who are undesirable nature in respect of their body (Physique). They are called Ashtonindatiyapurusha. One of them is "Ati-Sthula". A person having heaviness and bulkiness of body due to extreme growth especially in udarvadi region is termed as "Sthula" and state of Sthula is called as "Sthaulya". In Ayurveda Sthaulya is one of predominant disease of kapha, involving kapha, meda as a dosha and dushya in pathogenesis.
Sthaulya is a bahudosha condition caused by derangement of agni in general and medodhatvaagni in particular. This leads to excessive production and accumulation of medodhatu thus obstructs the flow of vata. In Ayurveda Sthaulya is considered under santharpanajanya, medopradoshaja vikara as well as kapha Pradhana vikara, where apatarpana treatment modalities like langhna, ushna, tikshna are indicated. 
Sthaulya being agnivaishamya and vatadushti so that bastikarma is considered to best treatment. Acharya Sushrut, lekhan basti which is one of the type of nirhua basti containing drugs like makshika, gomutra, kshara and Haridradi dravya which medohara and lekshana property. According to Acharya Charaka Sthaulya chikitsa ruksha, ushna and tikshna. Haridradi basti dravya having property is ushna, tikshna, lekshniya and karshna reduced kapha and vata dosha and medodhatu.

Hypothesis 
Null Hypothesis:
Haridradi basti is not effective in the management of Sthaulya.

Alternative Hypothesis:
Haridradi basti is effective in the management of Sthaulya.


 
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