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
|
|
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
|
|
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. |