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CTRI Number  CTRI/2020/04/024613 [Registered on: 14/04/2020] Trial Registered Prospectively
Last Modified On: 27/02/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   treatment of avabuka(frozen shoulder) with agnikarna and physiotherapy 
Scientific Title of Study   A comparative clinical effect of Agnikarma and Physiotherapy along with Dashmooladi Kwatha in the management of Avabahuka w.s.r. 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  Manisha Kapadiya 
Designation  Research scholar 
Affiliation  Institute for post graduate teaching and research in ayurveda 
Address  6th floor department of shalyatantra IPGT AND RA Gujarat Ayurved university campus Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  9974047713  
Fax    
Email  manisha.kapadiya15@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Tukaram Sambhaji Dudhamal 
Designation  Associate professor and I/C HOD 
Affiliation  institute for post graduate teaching and research in ayurveda 
Address  6th floor department of shalyatantra IPGT AND RA Gujarat Ayurved university campus Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  9428671939  
Fax    
Email  drtsdudhamal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Tukaram Sambhaji Dudhamal 
Designation  Associate professor and I/C HOD 
Affiliation  institute for post graduate teaching and research in ayurveda 
Address  6th floor department of shalyatantra IPGT AND RA Gujarat Ayurved university campus Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  9428671939  
Fax    
Email  drtsdudhamal@gmail.com  
 
Source of Monetary or Material Support  
Institute for post graduate teaching and research in Ayurveda Jamnagar Gujarat pin no 361008 
 
Primary Sponsor  
Name  Institute for post graduate teaching and research in ayurved 
Address  Gujarat Ayurved university campus Jamnagar Gujarat India pin no 361008 
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 
Manisha Kapadiya  IPGT AND RA hospital jamnagar  IPGT and RA hospital opd no 2 shalya department Jamnagar
Jamnagar
GUJARAT 
9974047713

manisha.kapadiya15@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M750||Adhesive capsulitis of shoulder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Agnikarma and Dashmooladi kwatha  In group A, patient will be treated with Agnikarma 4 sitting in 1 month as well as Dashmooladi kwatha 50 ml will be given at evening for 1 month  
Comparator Agent  physiotherapy and Dashmooladi kwatha  Pendular exercises, Isometric exercises, muscle strengthening exercise 10-15 repetition of each exercises twice a day for 1 month.Dashmooladi kwatha 50 ml at evening time for 1 month  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1)Patients suffering from Avabahuka (Pain and Stiffness in shoulder region or upper arm and Restricted range of motion of shoulder joint (ROM)
2)Patients with the age group 40-70 years irrespective of sex religion occupation socio-economic status etc will be included in the study
3) Patients with controlled diabetes mellitus (FBS: <140mg/dl, PPBS:<180mg/dl)
4)Patients fit for Agnikarma
5)Duration of frozen shoulder up to 2 years
 
 
ExclusionCriteria 
Details  1) Age below 40 years and above 70 years
2) Shoulder joint dislocation/ fracture
3) Patients of uncontrolled Diabetes mellitus(FBS: >140mg/dl, PPBS:>180mg/dl)
4) Other diseases like Paralysis, Parkinson’s disease, cardiac diseases, renal diseases and endocrine diseases, severe Anemia, and Malignancy,
5) Pregnant and lactating female
6) Patients contraindicated for Agnikarma as per classics
7)Rotator cuff injuries
8)Recent history of trauma in the affected shoulder
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Relief in signs and symptoms of Avabahuka(frozen shoulder)  After 1 month of treatment 
 
Secondary Outcome  
Outcome  TimePoints 
improves quality of life of person   after 1 month 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   16/04/2020 
Date of Study Completion (India) 30/12/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Kapadiya M, Joshi F, Dudhamal TS. Agnikarma with Adjuvant Drug in the Management of Frozen Shoulder (Avabahuka) – A Case Report. Asian Pac. J. Health Sci., 2021;8(4):75-78 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  


The research study entitled “A comparative clinical effect of Agnikarma and Physiotherapy along with Dashmooladi Kwatha in the management of Avabahuka w.s.r. to Frozen Shoulder.” Was aimed to evaluate and compare the efficacy of Agnikarma and physiotherapy along with Dashmooladi Kwatha in the management of Avabahuka w.s.r. frozen shoulder. This trial was summarized in review of literature, including Ayurvedic literature and modern literature of Avabahuka (frozen shoulder) and literature of Agnikarma.

Drug review comprises classical narration of Dashmooladi Kwatha with Pharmacognostical and analytical study.

Clinical study stats the open labelled comparative clinical study of 111 clinical cases of frozen shoulders divided into two groups according computer generated randomization chart. Total 168 cases were screened through out the study with shoulder joint pain, among which total 111 cases were frozen shoulder falling in the study criteria. 57 cases were excluded due to failure for enrollment in the study. Rest 111 cases were enrolled for the study, 11 cases were dropped out and 100 cases completed the course of treatment and follow up as mentioned in study In group A (n=55), frozen shoulder patients managed through 4 sittings of Samyaka Bindu Dagdha Agnikarma with red hot Panchadhatu shalaka at most tender point of affected shoulder in seven days interval and Dashmooladi kwatha 50 g orally at evening after meal advised for 28 days. In group B (n= 56), physiotherapy was advised two times a day for fifteen minutes in each session with Dashmooladi kwatha 50 g orally at evening after meal advised for 28 days. Among which 49 patients in group A while 51patients in group B completed the treatment and follow up as per protocol. 6 patients in group A and 5 patients in group B were dropped out from the study. All the cases were screened for essential haematology, urology, bio-chemical and radiological investigations prior their enrolment for the study.  The effect of the treatment was assessed on the basis of relief in Pain, stiffness, Muscle power, muscle wasting, sensory loss, disability of arm, shoulder and hand (DASH) Score where subjective criteria were assessed by VAS scale and gradation. Active ranges of movements (AROM), were considered as the objective parameters. The AROM namely flexion, extension, abduction, adduction, internal rotation & external rotations in abduction were recorded according to the actual values of goniometric readings. All the cases were followed up for 1 month. The observed results in the study were subjected to statistical calculation to derive final conclusion.  

Discussion on study was made on demographic observations and clinical findings. Conclusion of clinical study suggest that both the groups treatment protocol have shown Highly significant effect in shoulder pain, stiffness, DASH Score, abduction, flexion, internal rotation, external rotation, ESR in managing the cases of frozen shoulder whereas Significant difference was observed in Extension through therapy in both the groups. Highly significant difference was observed in comparative effect of therapy in pain, stiffness, DASH score and internal rotation whereas significant difference was noted in abduction. Non-significant difference was observed in comparative effects of therapy in relieving restricted flexion, extension, external rotation, ESR. Finally, study concluded that Agnikarma with Dashmooladi kwatha have better effect to manage shoulder pain as well as to restore joint function as compare to physiotherapy with Dashmooladi kwatha in the management of Avabahuka (frozen shoulder). Thus, it declares that, alternative hypothesis is accepted and null hypothesis is rejected i.e., Agnikarma along with Dashmooladi Kwatha is more effective than physiotherapy along with Dashmooladi Kwatha in the management of Avabahuka w.s.r. to frozen shoulder.

 


 
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