| 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
|
|
|
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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | svedanam, सà¥à¤µà¥‡à¤¦à¤¨à¤®à¥ | (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 | | 2 | Comparator Arm | Procedure | - | __nasyam, नसà¥à¤¯à¤®à¥ | (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 | | 3 | Comparator Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•रà¥à¤® | (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. |