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CTRI Number  CTRI/2023/02/049963 [Registered on: 22/02/2023] Trial Registered Prospectively
Last Modified On: 23/01/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Ayurvedic management of irritable bowel syndrome through counselling therapy and healing therapy 
Scientific Title of Study   The Assessment of Satva in the Manifestation of Grahani Roga and Management through Satvavajaya and Daivavyapashraya Chikitsa -A comparative clinical study  
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 Sandeep Desai 
Designation  Associate professor Department of samhita siddhanta ,room no 13 
Affiliation  Ayurveda mahavidyalaya hubli 
Address  Ayurveda mahavidyalaya heggeri extension department of samhita siddhanta room no 13 old hubli hubli 580024
Near someshwar steel works fort road old hubli
Dharwad
KARNATAKA
580024
India 
Phone  9845765863  
Fax    
Email  desaisandeep17@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Arun vaidya 
Designation  professor department of samhita siddhanta 
Affiliation  parul institute of Ayurveda 
Address  professor department of samhita siddhanta room no 103parul institute of Ayurveda p.o limbda Ta Waghodia Dist vadodara vadodara gujarat
same as address 1
Vadodara
GUJARAT
391760
India 
Phone  9824917034  
Fax    
Email  arun.vaidya@paruluniversity.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Arun vaidya 
Designation  professor department of samhita siddhanta 
Affiliation  parul institute of Ayurveda 
Address  professor department of samhita siddhanta room no 103 parul institute of Ayurveda Ta Waghodia Dist vadodara vadodara gujarat
same as address 1
Vadodara
GUJARAT
391760
India 
Phone  9824917034  
Fax    
Email  arun.vaidya@paruluniversity.ac.in  
 
Source of Monetary or Material Support  
parul university of Ayurveda vadodara gujarat 
 
Primary Sponsor  
Name  parul institute of Ayurveda  
Address  parul institute of Ayurveda p.o limbda Ta Waghodia,Distvadodara gujarat 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Ayurveda Mahavidyalaya hubli  amv hubli heggeri extension old hubli 580024 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr sandeep Desai  Ayurveda mahavidyalaya hubli  Heggeri extension Department of samhita siddhanta room no13 old hubli hubli 580024
Dharwad
KARNATAKA 		 9845765863

desaisandeep17@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
parul university of Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K318||Other specified diseases of stomach and duodenum. Ayurveda Condition: GRAHANIDOSHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-satvAvajaya-cikitsA, सत्वावजय-चिकित्सा (Procedure Reference: charaka samhita, Procedure details: Medicine: Satvavajaya chikitsa along with kutajaghana vati (30days • Dosage: 250 mg thrice a day. • Anupana: Takra (30ml) • Duration: 40 days • Kaala: Adho Bhakta • Follow up: Once in a week for a period of six weeks. )
(1) Medicine Name: kutaja ghana vati, Reference: siddayoga sangraha, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 250(mg), Frequency: tds, Duration: 30 Days
2Comparator ArmDrugClassical(1) Medicine Name: kutajaghanavati, Reference: siddayogasngraha, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -takra), Additional Information: -
3Comparator ArmProcedure-daivavyapASraya-cikitsA, दैवव्यपाश्रय-चिकित्सा (Procedure Reference: charaka samhita, Procedure details: Daivavyapshrayachikitsa with the Mantra Medha sukta listening or reading 3times at brahmi muhurta along with kutajaghana vati (30days)Dosage: 250 mg thrice a day. • Anupana: Takra (30ml) • Duration: 40 days • Kaala: Adho Bhakta Follow up: Once in a week for a period of six weeks )
(1) Medicine Name: kutajaghanavati, Reference: siddhayogasangraha, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 250(mg), Frequency: tds, Duration: 30 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Diagnosed cases of Grahani roga .

Subjects willing to participate in the study.

 
 
ExclusionCriteria 
Details  Patients with serious Systemic Disorders and other serious Mental Disorde 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The data, which are obtained by the clinical trial, will be statistically analyzed by applying relevant statistical test.
Relief of Diagnostic parameters before and after the treatment will be assessed and the result will be recorded.
Gradations: The Internationally accepted Gastraintestional Rating Scale is considered for the scoring.

 		 time duration of 6 weeks will be done 
 
Secondary Outcome  
Outcome  TimePoints 

The data, which are obtained by the clinical trial, will be statistically analyzed by applying relevant statistical test.
Relief of Diagnostic parameters before and after the treatment will be assessed and the result will be recorded.
Gradations: The Internationally accepted Gastraintestional Rating Scale is considered for the scoring
 		 6 weeks is time duration 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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   N/A 
Date of First Enrollment (India)   06/03/2023 
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="0"
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   Ayurveda is the life science which deals with both health as well as diseases .the shareerika dosha vata,pitta,kapha and manasika dosha raja and tama are responsible for the manifestation of diseases both are interlinked with each other ,body follows the mind vise versa.aAyurveda says the impairment of agni leads to many diseases ,Grahani roga is one among them .the clinical features are muhurbadda muhur drava mala pravrutti,aruchi etc and it can be corelated to modern diseases irritable bowel syndrome due to similar symptoms alternate bowel habits ,abdominal pain etc.Ayurveda explains the causitive factors for manifestation od grahani roga as vishamashana,mithya ahara vihara vihara,vegadharana etc,with silently manasika factors as chinta ,kroda etc.so the study has been under taken to cure both the elements.so here Satvavajaya and Daivavapshraya chikitsa have been undertaken to control psychological factors and to find out the effecacy of treatment procedure.so study has been entetitiled with THE ASSESSMENT OF SATVA IN MANIFESTATION OF GRAHANI ROGA AND MANAGMENT THROUGH SATVAVAJAYA CHIIKITSA AND DAIVAVYAPASHRAYA CHIKITSA-ACOMPARATIVE CLINICAL STUDY 
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