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CTRI Number  CTRI/2025/08/092236 [Registered on: 04/08/2025] Trial Registered Prospectively
Last Modified On: 12/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Study of Doshahara Basti on Vata Vyadhis 
Scientific Title of Study   Study of efficacy of Doshahara Basti in Upasthambita Vata Vyadhis - A case series 
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 Sanghamitra Patnaik 
Designation  Professor & HOD 
Affiliation  Sushrutha Ayurvedic Medical College and Hospital 
Address  room no2 Panchakarma OPD Sushrutha Ayurvedic Medical College and Hospital Jigani Bengaluru

Bangalore
KARNATAKA
560105
India 
Phone  9448035377  
Fax    
Email  ayursanghamitra@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sanghamitra Patnaik 
Designation  Professor & HOD 
Affiliation  Sushrutha Ayurvedic Medical College and Hospital 
Address  room no2 Panchakarma OPD Sushrutha Ayurvedic Medical College and Hospital Jigani Bengaluru

Bangalore
KARNATAKA
560105
India 
Phone  9448035377  
Fax    
Email  ayursanghamitra@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sanghamitra Patnaik 
Designation  Professor & HOD 
Affiliation  Sushrutha Ayurvedic Medical College and Hospital 
Address  room no2 Panchakarma OPD Sushrutha Ayurvedic Medical College and Hospital Jigani Bengaluru

Bangalore
KARNATAKA
560105
India 
Phone  9448035377  
Fax    
Email  ayursanghamitra@gmail.com  
 
Source of Monetary or Material Support  
Panchakarma OPD Sushrutha Ayurvedic Medical College and Hospital Prashanti Kutiram Jodi Bingipura Jigani Hobli Anekal Taluk Bengaluru Karnataka 560105  
 
Primary Sponsor  
Name  Sushrutha Ayurvedic Medical College and Hospital 
Address  Prashanti Kutiram Jodi Bingipura Jigani Hobli Anekal Taluk Bengaluru 560105 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
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 Sanghamitra Patnaik  Sushrutha Ayurvedic Medical College and Hospital  Room no2 Panchakrma OPD Prashanti Kutiram Jodibingipura Jigani Hobli Anekal Taluk Bengaluru 560105
Bangalore
KARNATAKA 
9448035377

ayursanghamitra@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SAMCH & H-IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M249||Joint derangement, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Doshahara Basti (Niruha Basti)  Madhu- 100ml (2 pala) Saindhava- 10gms (1/2 karsha) Sneha (Guggulu tikitaka Ghrita) - 100ml (2 pala) Kalka (Shatahva) - 30gms (3 karsha) Kwatha (Erandamoola, Rasna, Shatapushpa, Vacha, Hingu, Devadaru) - 350ml (8pala) Anuvasana – Guggulu Tiktaka Ghrita o Dose : Niruha Basti – 570ml Anuvasana Basti (Guggulu Tikitaka Ghrita) – 80ml o Route of Administration : Anal route o Time of Administration : Niruha - Before food, Anuvasana – After food o Duration of therapy :Yoga Basti (8 days) 1st day Anuvasana 2nd day Niruha 3rd day Anuvasana 4th day Niruha 5th day Anuvasana 6th day Niruha 7th day Anuvasana 8th day Anuvasana  
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  • Diagnosed cases of Upathambita Vatavyadhis like Manyastamba Apabahuka Kaphaja Gridrasi etc of either sex will be taken.
• Patients fit for Basti Procedure according to classics
 
 
ExclusionCriteria 
Details  • Patients not fir for Basti
• Individuals suffering from Chronic diseases and complications, those who have underwent major surgical procedures.
• Pregnant ladies & lactating women
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Efiicacy of Doshahara Basti
on subjective parameters and objective parameters 
0 day
8th day
16th day 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
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)   13/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  13/08/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Need of the study:

·       Good health needs following of regular Dinacharya, Ratricharya and Ritucharya of Ayurveda Science. The main aim is “Swasthyashya Swasthya Rakshanam, Athurasya Roga Prashamanam”. External environmental changes have the impact on the human body to disturb the equilibrium of the Doshas i.e. Dosha Vaishamya, if body is unable to adopt itself to stressors due to changes in specific traits of seasons. Ayurveda accepts if we keep the pearl in pure water for a longer period, there is the chances of deposition of mud in it. In the same way for healthy individual also there may be the chances of Dosha Vaishamya during the seasonal changes. Hence to overcome this condition a beautiful concept like Ritu Shodhana (Seasonal Purification) mentioned in Ayuredic life Sceince which plays a vital role for the prevention of diseases. In present scenario due to busy schedule and irregular diet habits, excess use of fast food, lack of physical activities, over stress people leads to production Ama in the body which results in Avarodhajanita Vata Vyadhis. i.e. Upastambita Vata Vyadhis in Ayurveda. This comes under the 80 types of Vata Vyadhi. Present study deals with Upastambita Vata Vyadhis like Kaphanubandhi Pakshagata,Kapha Vataja Apabahuka, Kapha Vataja Gridrasi, ManyaSthamba etc.

·       Varsha Ritu - Mid-July to Mid-September, is the beginning season of Visarga Kaala, in which vitiation of all the three Doshas, Specifically Vata Dosha and also depletion of agni leading to aggravation of all those amaja conditions.

·       Basti is the line of treatment in Varsha Ritu. Hence an effort has been made to access the role of Doshahara Basti in above conditions during Varsha ritu as Ritu Shodhana.

 

·       The ingredients of Doshahara basti like Madhu and Sneha – Guggulu Tiktaka Ghrita, Erandamoola Kwatha along with Saindhava, Rasna, Devadaru, Hingu, Vacha, Shatahava has Amapachaka and as well as Vatanashaka effect, so this study is planned.

 

Primary Objective:

q To assess the effect of Varshika Basti on Upasthambita Vata Vyadhi

Secondary Objective:

q To assess the efficacy of Doshahara Basti in Upasthambita Vata Vyadhi

 

Materials & Methods:

u      Study Type    : Clinical Pilot study

u      Level of study:  Out-patient Department (OPD) and In-patient Department (IPD) of SAMC&H

u      End Point        : Efficacy and Safety. 

u      No. of Groups  : One

u      Sample Size     : 10  subjects

 

Inclusion Criteria:

·       Aged between 18 – 60 Years.

·       Diagnosed cases of Upathambita Vatavyadhis of either sex will be taken.

·       Basti Yogyas

 

Exclusion Criteria:

·       Basti Ayogyas

·       Individuals suffering from Chronic diseases and complications, those who have underwent major surgical procedures.

·       Pregnant ladies & lactating women

 

Treatment Interventions:

 

Administration method will be followed as per the classical text.

Form: Doshahara Basti – Niruha ingredients

     Madhu- 100ml (2 pala)

     Saindhava- 10gms (1/2 karsha)

     Sneha (Guggulu tikitaka Ghrita) - 100ml (2 pala)

     Kalka (Shatahva) - 30gms (3 karsha)

     Kwatha (Erandamoola, Rasna, Shatapushpa, Vacha, Hingu, Devadaru) - 350ml    

                                                                                                                          (8pala)

           Anuvasana – Guggulu Tiktaka Ghrita

 

o  Dose                               : Niruha Basti – 570ml

                                              Anuvasana Basti (Guggulu Tikitaka Ghrita) – 80ml

o  Route of Administration : Anal route

o  Time of Administration : Niruha - Before food, Anuvasana – After food

o  Duration of therapy         :Yoga Basti (8 days)

Assessment Criteria: Subjective

 

Subjective

Upastambita vatvyadhi Lakshana

Vibandh

Bahuvedana

Asthi-parva Stambh

Sankoch

Gourava

Tandra

Shotha

Sparshasahatwa

Ushna sparsh

Daha

Bheda,Toda

Arti,

Ayasa

Agnisada

Snehasyadi Vruddhi

Jwara

 

Scoring: No, mild, moderate, severe grading’s will be used from 0-4

 

Objective

Lab investigation – CBC, ESR, CRP

 

Assessment duration:

Before treatment, at the end of the treatment i.e., on 8th day, after 16 days of treatment i.e. 24th day (Dwi Parihara Kala according to Charaka)

 

Statistical analysis: paired T test

 

Conclusion:

·       Present aim of the study is to evaluate “Effect of Varshika Basti in Upastambita Vata Vyadhis – A case series w.s.r Doshahara Basti”

·       In Varsha Ritu all three doshas get vitiated, specifically vata. There in impairment in agni leading to Amajanita Vata Vyadhis if not followed proper diet and regimens.

·       As the selected ayurvedic prepration is Doshahara basti – most of the dravyas have Tridosha Hara properties, improves Agni, and removes Ama which helps to show its positive effect on Upasthambita Vata Vyadhis as a part of Ritu Shodhana.

 
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