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CTRI Number  CTRI/2024/12/078396 [Registered on: 20/12/2024] Trial Registered Prospectively
Last Modified On: 12/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   COMPARATIVE CLINICAL STUDY OF TRAYODASANGA GUGGLU WITH AND WITHOUT MASHATAILA NASYAKARMA IN THE MANAGMENT OF AVABAHUKA  
Scientific Title of Study   CLINICO-COMPARATIVE CLINICAL STUDY OF TRAYODASANGA GUGGLU WITH AND WITHOUT MASHATAILA NASYAKARMA IN THE MANAGEMENT OF AVABAHUKA W.S.R. TO FROZEN SHOULDER 
Trial Acronym  TA,NK,AVH,FZ 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Amisha Patel 
Designation  PHD SCHOLAR 
Affiliation  Maganbhai Adenwala Mahagujarat University,Nadiad,J.S.Ayurveda Mahavidyalaya,Nadiad 
Address  J S Ayurveda Mahavidyalaya college Road Nadiad Gujrat kheda 387001 India
J S Ayurveda Mahavidyalaya college Road Nadiad Gujrat kheda 387001 India
Kheda
GUJARAT
390023
India 
Phone  08320032175  
Fax    
Email  patel.amisha988@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Kalapi B Patel 
Designation  HOD Panchkarma department Medical suprident and Principal  
Affiliation  Maganbhai Adenwala Mahagujarat University,Nadiad,J.S.Ayurveda Mahavidyalaya,Nadiad 
Address  J S Ayurveda Mahavidyalaya college Road Nadiad Gujrat kheda 387001 India J S Ayurveda Mahavidyalaya college Road Nadiad Gujrat kheda 387001 India
J S Ayurveda Mahavidyalaya college Road Nadiad Gujrat kheda 387001 India J S Ayurveda Mahavidyalaya college Road Nadiad Gujrat kheda 387001 India
Kheda
GUJARAT
387001
India 
Phone  09428661664  
Fax    
Email  drkalapi@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Dr Kalapi B Patel 
Designation  HOD Panchkarma department Medical suprident and Principal  
Affiliation  Maganbhai Adenwala Mahagujarat University,Nadiad,J.S.Ayurveda Mahavidyalaya,Nadiad 
Address  J S Ayurveda Mahavidyalaya college Road Nadiad Gujrat kheda 387001 India J S Ayurveda Mahavidyalaya college Road Nadiad Gujrat kheda 387001 India
J S Ayurveda Mahavidyalaya college Road Nadiad Gujrat kheda 387001 India J S Ayurveda Mahavidyalaya college Road Nadiad Gujrat kheda 387001 India
Kheda
GUJARAT
387001
India 
Phone  09428661664  
Fax    
Email  drkalapi@rediffmail.com  
 
Source of Monetary or Material Support  
Pharmacy of KJ Institute of Ayurveda  
 
Primary Sponsor  
Name  J S Ayurveda Mahavidyalaya Maganbhai Adenewala Mahagujrat University Nadiad 
Address  J S Ayurveda Mahavidyalaya college road Nadiad Gujrat 387001 
Type of Sponsor  Research institution and hospital 
 
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 Amisha P Patel  Kashiba Ayurvedic Hospital  K J Campus opp ITI At Javla Po Savli Vadodara 391770
Vadodara
GUJARAT 		 08320032175

patel.amisha988@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
nstitutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M959||Acquired deformity of musculoskeletal system, unspecified. Ayurveda Condition: AVABAHUKAH, (2) ICD-10 Condition:M958||Other specified acquired deformities of musculoskeletal system. Ayurveda Condition: AVABAHUKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-marSaH, मर्श (Procedure Reference: Charaka Sushruta Astangahridaya, Procedure details: Nasya with Masha taila for 15 days)
2Comparator ArmDrugClassical(1) Medicine Name: Trayodasanga Gugglu, Reference: Bhaisajya Ratnavali, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: warm water), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients having sign and symptoms of Avabahuka-frozen shoulder
Patients presenting with classical signs and symptoms of Avabahuka like restricted movement of shoulder joint, Shoulder joint pain, stiffness.
Patient having condition of Diabetes Mellitus.
Patients within the age group of 18 to 70 years.
Patients Yogya for Nasya Karma
 
 
ExclusionCriteria 
Details  Patients below 18 years and above 60 years of age
Patients of shoulder joint dislocation/fracture.
Patients Ayogya for Nasya Karma
Pregnant and lactating women.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To find out effect of ayurvedic treatment in sign and symptoms of the patient of Avabahuka  To find out effect of ayurvedic treatment in sign and symptoms of the patient of Avabahuka 1 month 
 
Secondary Outcome  
Outcome  TimePoints 
Improve Quality of life of the patients  1 month after competition of treatment 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   27/12/2024 
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="0"
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  

This is an open labeled randomized comparative clinical trial study consist minimum 50 patients of Avabahuka. Objective  of this clinical study is to study and observe the efficacy and effectivness of Mashataila Nasyakarma with Trayodaśāuga guggulu and alone Trayodaśāuga guggulu in the management of Avabāhuka (frozen shoulder) and clinical entity of frozen shoulder syndrome through Ä€yurveda also improve quality of the life of the patients.

 

 
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