| CTRI Number |
CTRI/2022/09/046084 [Registered on: 30/09/2022] Trial Registered Prospectively |
| Last Modified On: |
29/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect Of Mahasalvana Pinda Sweda (Medicated Herbal Powder is prepared in the form of Bolus) And Kolakulathadi Choorna Pinda Sweda (Combination of Herbal Powder used for external Therapy in the form of Bolus) In Janusandigatavata (Osteoarthritis of Knee). |
|
Scientific Title of Study
|
A Comparative Clinical Study On Mahasalvana Pinda Sweda And Kolakulathadi Choorna Pinda Sweda In Janusandigatavata. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr JOHNCY JOHN |
| Designation |
P G SCHOLAR |
| Affiliation |
ALVAS AYURVEDA MEDICAL COLLEGE |
| Address |
ALVAS AYURVEDA MEDICAL COLLEGE
VIDYAGIRI,MOODBIDIRE
D K DISTRICT
KARNNATAKA, INDIA
PG SCHOLAR
DEPARTMENT OF PG STUDIES IN PANCHAKARMA
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9061522983 |
| Fax |
|
| Email |
sralphyshsacredheart@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikram Kumar MD PhD |
| Designation |
Professor, Guide |
| Affiliation |
ALVAS AYURVEDA MEDICAL COLLEGE |
| Address |
Alvas Ayurveda Medical College
Vidyagiri,Moodbidre
Dakshina Kannada District
Karnnataka, India
Professor, Guide
Department of Pg Studies in Panchakarma
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9483141326 |
| Fax |
|
| Email |
vikramkumar83@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr JOHNCY JOHN |
| Designation |
P G SCHOLAR |
| Affiliation |
ALVAS AYURVEDA MEDICAL COLLEGE |
| Address |
Alvas Ayurveda Medical College
Vidyagiri,Moodbidre
Dakshina Kannada District
Karnnataka, India
PG Scholar
Department Of PG Studies In Panchakarma
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9061522983 |
| Fax |
|
| Email |
sralphyshsacredheart@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Panchakarma 3rd floor Alvas Ayurveda Medical College and Hospital Vidhyagiri Moodbidri |
|
|
Primary Sponsor
|
| Name |
Dr JOHNCY JOHN |
| Address |
PG Scholar
Department Of PG Studies In Panchakarma
Alvas Ayurveda Medical College,Vidyagiri
Moodbidre
Dakshina Kannada District,Karnnataka |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Johncy John |
Alvas Ayurveda Medical college and Hospital Moodbidri |
OPD of Alvas Ayurveda Medical college and Hospital
Vidhyagiri, moodbidri
Dakshina Kannada
KARNATAKA |
9061522983
sralphyshsacredheart@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Clinical Ethics Committee Alvas Ayurveda Medical College Vidyagiri Moodbidri |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | piNDasvedaH, पिणà¥à¤¡à¤¸à¥à¤µà¥‡à¤¦à¤ƒ Pradhan Karma | (Procedure Reference: yogarathnakara vata vyadi chikitsadhikara, Procedure details: All the drugs will be made into fine powder individually and 300 gram of choorna wiil be mixed with 400 ml of dhanyamla and 2 pottali will be prepared.
patient is made to lie in supine position exposing the knee.
sthanika abhyanga with plane ghritha on knee for 5 minutes.
pottali will be heated in ghritha.
one pottali will be taken and will be applied over the knee joint after confirming the temperature of the pottali on the dorsum of palm.
both pottali will be used alternatevely after rehe)
| | 2 | Intervention Arm | Procedure | - | piNDasvedaH, पिणà¥à¤¡à¤¸à¥à¤µà¥‡à¤¦à¤ƒ | (Procedure Reference: charaka samhitha, Procedure details: All the drugs will be made into fine powder individually and 300 gram of choorna wiil be mixed with 400 ml of dhanyamla and 2 pottali will be prepared. patient is made to lie in supine position exposing the knee. sthanika abhyanga with plane ghritha on knee for 5 minutes. pottali will be heated in ghritha. one pottali will be taken and will be applied over the knee joint after confirming the temperature of the pottali on the dorsum of palm. both pottali will be used alternatevely after reheating)
|
|
|
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Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Sandhi Shoola ( Pain in Knee Joint)
2.Sandhi Atopa (Crepitus)
Associated Symptoms
1.Sandhi Shotha (Swelling over knee joint)
2.Prasarana Akumchanayo Pravruthischa Sa Vedana (Pain during Flexion and Extension of Knee Joint).
|
|
| ExclusionCriteria |
| Details |
1.Congenital bony deformity of knee Joint
2.Rheumatoid Arthritis
3.Gouty Arthritis.
4.Patients with Acute Traumatic Injury to the knee. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pacification of symptoms of janusandhigata vata.
to evaluate the effect of Mahasalvana pinda sweda in janusandhigata vata. and compare the effect of mahasalvana pinda sweda and kolakulathadi pinda sweda in janusandhigta vata. |
7 days of Treatment. follow up on 15th day,30th day,45th day and 60th day |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
not applicable |
|
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Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
10/10/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
It is a comparative clinical study to evaluate the efficacy of Mahasalvana pinda sweda and Kolakulathadi pinda sweda in janusandhigata vata. Treatment will be given for 7 days and total 60days of follow up. 20 patients in each group.That will be conducted in Alvas Ayurveda Medical College and Hospital Vidyagiri, Moodbidri.
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