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CTRI Number  CTRI/2024/05/066993 [Registered on: 08/05/2024] Trial Registered Prospectively
Last Modified On: 25/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Mashasaindhav tail nasya in comparison with jambeera pinda sweda and agnikarma in frozen shoulder 
Scientific Title of Study   Comparative Clinical Trial To Evaluate The Efficacy Of Mashasaindhav Tail Nasya, Jambeera Pinda Sweda And Agnikarma In Avabahuka With Special Reference To Frozen Shoulder 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vijay Prabhakar Shingade 
Designation  Ph D Scholar 
Affiliation  Honorable Shri Annasaheb Dange Ayurved Medical College and Post Graduate Research Center Ashta  
Address  Department of Panchakarma, Honorable Shri Annasaheb Dange Ayurved Medical College and Post Graduate Research Center Ashta Tal Walwa Dist Sangli Maharashtra 416301

Sangli
MAHARASHTRA
416301
India 
Phone  9766451959  
Fax    
Email  drvijayshingade@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Alaknanda Kulkarni 
Designation  Ph D Guide 
Affiliation  Honorable Shri Annasaheb Dange Ayurved Medical College and Post Graduate Research Center Ashta  
Address  Department of Panchakarma, Honorable Shri Annasaheb Dange Ayurved Medical College and Post Graduate Research Center Ashta Tal Walwa Dist Sangli Maharashtra 416301

Sangli
MAHARASHTRA
416301
India 
Phone  9689049577  
Fax    
Email  vdalaknandakulkarni@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Alaknanda Kulkarni 
Designation  Ph D Guide 
Affiliation  Honorable Shri Annasaheb Dange Ayurved Medical College and Post Graduate Research Center Ashta  
Address  Department of Panchakarma, Honorable Shri Annasaheb Dange Ayurved Medical College and Post Graduate Research Center Ashta Tal Walwa Dist Sangli Maharashtra 416301

Sangli
MAHARASHTRA
416301
India 
Phone  9689049577  
Fax    
Email  vdalaknandakulkarni@gmail.com  
 
Source of Monetary or Material Support  
Department of Panchakarma, Dr M.N. Agashe Charitable Hospital Satara Maharashtra Affiliated To Seth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya Satara Maharashtra 415002 
Department of Panchakarma, Honorable Shri Annasaheb Dange Ayurved Medical College and Post Graduate Research Center Ashta Tal Walwa Dist Sangli Maharashtra 416301  
GMP Certified Pharmacy 
 
Primary Sponsor  
Name  Dr Vijay Prabhakar Shingade 
Address  Department of Panchakarma, Dr M.N. Agashe Charitable Hospital Satara Maharashtra Affiliated To Seth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya Satara Maharashtra, India, PIN 415002 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vijay Prabhakar Shingade  Dr M.N. Agashe Charitable Hospital Satara   Opd room No 6 Department of Panchakarma
Satara
MAHARASHTRA 
9766451959

drvijayshingade@gmail.com 
Dr Vijay Prabhakar Shingade  Hon Shri Annasaheb Dange Ayurved Medical College And Hospital Ashta Sangli   Opd room No 9 Department Of Panchakarma
Sangli
MAHARASHTRA 
9766451959

drvijayshingade@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
institutional ethics committee Hon Shri Annasaheb Dange Ayurved Medical College Ashta Sangli  Approved 
Institutional ethics committee Seth chandanmal mutha Aryangla vaidyak mahavidyalaya satara  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M00-M99||Diseases of the musculoskeletal system and connective tissue. Ayurveda Condition: AVABAHUKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-svedanam, स्वेदनम् (Procedure Reference: vangasen vatarogadhikar/112, Procedure details: Purva karma sthanic snehana with tila taila Pradhan karma application of heated jambeera pottali for 10 minutes over Paschat karma cleaning of body part)
(1) Medicine Name: Jambeera, Reference: charak sutrasthan 14/25, Route: Topical, Dosage Form: Not Applicable, Dose: 2(NA), Frequency: od, Duration: 14 Days
2Comparator ArmProcedure-__nasyam, नस्यम् (Procedure Reference: Ashtang hriday chikitsa sthan 21/44, Procedure details: Purva karma sthanic snehana with Tila taila bashpa swedana with Dashamool kwatha Pradhan karma Nasya karma with Mashasaindhav tail Paschat karma Dhoompana with Dhoomvarti Gandusha with koshnajala )
(1) Medicine Name: Mashasaindhav tail , Reference: Chakradatta vatarogadhikar/142, Route: Nasal, Dosage Form: Taila, Dose: 4(ml), Frequency: od, Duration: 14 Days
3Comparator ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: sushrut sutrasthan 12/10, Procedure details: Purva karma marking of tender points, draping Pradhan karma Agnikarma with suvarna shalaka at marking points paschat karma Application of aloe vera pulp at agnikarma points)
(1) Medicine Name: Suvarna, Reference: ashtang sangraha sutrasthan 40/3, Route: Topical, Dosage Form: Not Applicable, Dose: 1(NA), Frequency: od, Duration: 5 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Those who are fit for nasya
Those who are fit for jambeera pinda sweda
Those who are fit for agnikarma
Patients will be selected irrespective of gender, occupation and habitat
age group 20-60 years
Patients presenting with classical clinical features of Avabahuka w.s.r. to Frozen Shoulder.



 
 
ExclusionCriteria 
Details  Those who are not fit for nasya karma
Those who are not fit for jambeera pinda sweda
Those who are not fit for agnikarma
Autoimmune disorders like SLE, RA etc.
Diabetic patients having diabetic neuropathy and increased glycemic index.
Dislocation and fracture of Shoulder joint.
Patients having thyroid disorders and tuberculosis

 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Centralized 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To study the efficacy of Mashasaindhav tail nasya, Jambeera pinda sweda and Agnikarma in Avabahuka  14 Days 
 
Secondary Outcome  
Outcome  TimePoints 
To find out an effective, economic and easily available curative therapy for the treatment of Avabahuka.

To study Nasya, jambeera pinda sweda and Agnikarma in detail with its mode of action.


To review the etiopathology of Avabahuka according to ayurvedic and modern aspect.

 
1 year 6 months
 
 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   15/05/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Avabahuka is one among the vatavyadhi which affects the normal functioning of the upper limbs, specially shoulder joint. Avabahuka can be correlated to frozen shoulder in modern science. Frozen shoulder is one of the most common disorder of the joint diseases. Research has shown a prevalence rate of frozen shoulder in the general population is 3% - 5% . Its peak incidence is between the ages of 40 - 60 yrs and is more common in women. Frozen shoulder clinically referred to as adhesive capsulitis, has been described as a condition of unknown etiology and characterized by gradually progressive, painful restriction of shoulder joint. The incidence of Frozen shoulder is increasing day by day. Due to Restricted movements of the affected joint, the life of the patient becomes miserable. Therefore there is a need of effective treatment to manage such a condition called frozen shoulder. The present study Randomized control Trials will be carried out with aim to evaluate the efficacy of Mashasaindhav tail nasya, Jambeera pinda sweda and Agnikarma in Avabahuka with special reference to frozen shoulder. For present study patients fulfilling the diagnostic criteria of Frozen Shoulder, between the age group of 20 to 60 years with irrespective of gender, religion, socioeconomic status will be selected. Calculated Sample size is 120, it is divided into 3 groups. So, 40 patients will be taken for study in each group. Mashasaindhav tail nasya, Jambeera pinda sweda and Agnikarma will be carried out in Group-A, Group-B and Group-C patients respectively. Trial drug for Group-A will be purchased from GMP certified pharmacy. This drug will be administered through nasal route with 4 ml quantity in each nostril for 14 days. Jambeera pinda sweda will be carried out in Group-B patients for 14 days. Agnikarma with suvarna shalaka  will be done in Group-C patients in 5 settings within 14 days. All SOP of Nasya karma, Jambeera pinda sweda and Agnikarma will be strictly followed during and after treatment. All the findings will be entered in case record form (CRF) and for better understanding tabulation and graphical presentation will be done. Observations will be drawn on before treatment (0th day), during treatment (7th day), after treatment (15th day) and at follow up (30th day). Result of study will be calculated statistically with appropriate statistical method. Result will be drawn on the basis of criteria of assessment and statistical analysis. Discussion will be done on the basis of observations and result obtained during the treatment. Summary will be drawn and whole thesis work will be summarized. Conclusion will be drawn strictly on the basis of statistical analyasis and will be unbiased.


 
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