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CTRI Number  CTRI/2024/07/071579 [Registered on: 30/07/2024] Trial Registered Prospectively
Last Modified On: 26/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Other (Specify) [panchakarma procedure]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effect of shashtika shali pinda sweda in patients of avabahuka with special reference to frozen shoulder  
Scientific Title of Study   A Randomized controlled clinical trial to study the effect of shashtika shali pinda sweda in avabahuka with special reference to frozen shoulder 
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 Shraddha Vijayprakash Lilhare 
Designation  PG student 
Affiliation  SMBT Ayurved College and Hosptal  
Address  Department of Panchakarma SMBT Ayurved college and Hospital Dhamangaon Nashik

Nashik
MAHARASHTRA
422403
India 
Phone  8208304112  
Fax    
Email  shraddha.lilhare25@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Pramod Mandalkar 
Designation  Professor 
Affiliation  SMBT Ayurved College and Hospital  
Address  Department of Panchakarma SMBT Ayurved college and Hospital Dhamangaon Nashik

Nashik
MAHARASHTRA
422403
India 
Phone  9604633832  
Fax    
Email  vdpramod31@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shraddha Vijayprakash Lilhare 
Designation  PG student 
Affiliation  SMBT Ayurved College and Hosptal  
Address  Department of Panchakarma SMBT Ayurved college and Hospital Dhamangaon Nashik

Nashik
MAHARASHTRA
422403
India 
Phone  8208304112  
Fax    
Email  shraddha.lilhare25@gmail.com  
 
Source of Monetary or Material Support  
Department of panchakarma, SMBT Ayurved college andhospital GMP certified pharmacy, nashik,422406 
 
Primary Sponsor  
Name  Dr Shraddha Vijayprakash Lilhare 
Address  Department of panchakarma SMBT Ayurved College and Hospital Dhamangaon, Nashik,422403 
Type of Sponsor  Other [Private Ayurvedic 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 Shraddha Vijayprakash Lilhare  SMBT Ayurved College and Hospital  OPD No.13 Department of Panchakarma SMBT Ayurved College and Hospital Dhamangaon Nashik
Nashik
MAHARASHTRA 		 8208304112

shraddha.lilhare25@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SMBT College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M255||Pain in joint. Ayurveda Condition: AVABAHUKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-piNDasvedaH, पिण्डस्वेदः (Procedure Reference: charak samhita sutrasthan -41, Procedure details: (Procedure Reference: charam samhita sutrastha 41, Procedure details: poorvakarma:preperation of balamoola decoction 500gm powered balamoola with 8 litres of water reduced upto 2litres,preparation of shashtika shali paste,preparation of shashtika shali bolus,heating of bolus, pradhankarma:position of patient-sitting application of sweda paschatkarma:note vitals duration-25-30minutes) (1) Medicine Name: Raktashali,Balamoola, Reference: bhaishajya ratnawali, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 500(g), Frequency: od, Duration: 25-30 min.)
(1) Medicine Name: raktashali, Reference: bhaishaya ratnawali, Route: Topical, Dosage Form: Ksheerpaka, Dose: 400(g), Frequency: od, Duration: 7 Days
(2) Medicine Name: balamoola, Reference: keraliya panchakarma chikita vigyan, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 500(g), Frequency: od, Duration: 7 Days
(3) Medicine Name: dugdha, Reference: keralia panchakarma chikitsa vigyan, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 800(ml), Frequency: bd, Duration: 7 Days
2Intervention ArmProcedure-piNDasvedaH, पिण्डस्वेदः (Procedure Reference: charak samhita sutrasthan, Procedure details: poorvakarma: selection and examination of patient . frying of leaves of bolus. pradhankarma: position of patientapplication of sweda changing the bolus cleaning of body paschat karma:rest for few minutes )
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  69.00 Year(s)
Gender  Both 
Details  patients having classical signs and sympyoms of Avabahuka,like pain stiffness and range of motion of shoulder joint
patients of all genders
age between20 to 69 years
economic status all
controlled diabetes mellitus 
 
ExclusionCriteria 
Details  patient with history of fracture or dislocation of shoulder joint
patient with traumatic infective neoplastic joint and cardiovascular disease
patients having rheumatoid arthritis as well as
congenital structural disorder
traumatic diseases like fracture of shoulder blade or collarbone 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in signs and symptoms of Avabahuka   7days 
 
Secondary Outcome  
Outcome  TimePoints 
where trial group is more effective than control group  18 months 
 
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 3 
Date of First Enrollment (India)   15/08/2024 
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="3"
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   The population based study from India shows prevalence of Avabahuka is 10%,it is one of the disease which is painful and affects normal routine of life.so there is a need to find an alternative solution of this problem ..present study of randomized controlled trial will be carried out to study the efficacy of shashtika shali pinda swed in avabahuka with special reference to frozen shoulder. For present study subjects between age group 20-69 will be taken irrespective of the religion ,gender ,socioeconomic status. sample size found 23 but for the sake of convenience  it is taken as 30,adding prevalence of 20%.Total 60 patients will be taken for the study with 30 patients in Group A(trial group) AND 30 patients in Group B(control group). shashtika shali pinda sweda is taken in Group A(trial group) and patra pinda swed is taken in GroupB (control group).trial and control drugs will be purchased from GMC certified pharmacy. procedure will be done with external application for 7 days .all SOP will be followed. all the findings will be entered in case record form .observations will be drawn before, during and after treatment .Result will be drawn with the help of statistical method .Discussion will be done on the basis of observations. summary will be drawn .conclusion will be drawn strictly on basis of statistical analysis and will be unbiased. 
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