| CTRI Number |
CTRI/2025/01/079551 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
27/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study on Medasaka and Gulimavu patra upnaha in sandhigata vata w.s.r. to osteoarthritis of knee joint |
|
Scientific Title of Study
|
A randomised clinical trail to compare the efficacy of Medasaka (Litsea Glutinosa Lour.) and Gulimavu [Persea macrantha (nees) Kosterm.] patra upnaha in sandhigata vata w.s.r. to osteoarthritis of knee joint |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Satish Patil |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharamsthala Manjunatheshwara College of Ayurveda Hospital and Research Centre Kuthpady Udupi |
| Address |
OPD-9 Department of Panchakarma Sri Dharamsthala Manjunatheshwara College of Ayurveda Hospital and Research Centre Kuthpady Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
8971260851 |
| Fax |
|
| Email |
drsatishpatil77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Padmakiran C |
| Designation |
BAMS MD(AYU) Ph.D Associate Professor Department of Panchakarma |
| Affiliation |
Sri Dharamsthala Manjunatheshwara College of Ayurveda Hospital and Research Centre Kuthpady Udupi |
| Address |
OPD-9 Department of Panchakarma Sri Dharamsthala Manjunatheshwara College of Ayurveda Hospital and Research Centre Kuthpady Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
9448953038 |
| Fax |
|
| Email |
kiranasdm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Padmakiran C |
| Designation |
BAMS MD(AYU) Ph.D Associate Professor Department of Panchakarma |
| Affiliation |
Sri Dharamsthala Manjunatheshwara College of Ayurveda Hospital and Research Centre Kuthpady Udupi |
| Address |
OPD-9 Department of Panchakarma Sri Dharamsthala Manjunatheshwara College of Ayurveda Hospital and Research Centre Kuthpady Udupi
KARNATAKA
574118
India |
| Phone |
9448953038 |
| Fax |
|
| Email |
kiranasdm@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharamsthala Manjunatheshwara Ayurveda Pharmacy Kuthpady Udupi Karnataka India - 574118 |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
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 |
| Dr Satish Patil |
Sri Dharamsthala Manjunatheshwara College of Ayurveda Hospital and Research Centre Kuthpady Udupi |
OPD-9 Department of Panchakarma
Udupi
KARNATAKA |
8971260851
drsatishpatil77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Dharamsthala Manjunatheshwara college of ayurveda Udupi Institutional Ethical Clearance Committe-Human |
Approved |
|
|
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 | Intervention Arm | Procedure | - | upanAhaH (niragniH), उपनाहः (निरग्निः) | (Procedure Reference: Susuruta Smahita, Procedure details: the patient is made to lie down in supine postion. the area is cleaned with lukewarm water and dried. the prepared paste is applied around the knee joint in the thickness of about 3-5mm. after application, it is covered by leaves then bandaged. the bandage should neither be loose nor too tight. it is left as it is for 4 hours.)
(1) Medicine Name: Medasaka Patra, Reference: Dravyaguna Vigyana, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 0(NA), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | upanAhaH (niragniH), उपनाहः (निरग्निः) | (Procedure Reference: Sushruta samhita, Procedure details: the patient is made to lie down in supine postion. the area is cleaned with lukewarm water and dried. the prepared paste is applied around the knee joint in the thickness of about 3-5mm. after application, it is covered by leaves then bandaged. the bandage should neither be loose nor too tight. it is left as it is for 4 hours.)
(1) Medicine Name: Gulimavu Patra, Reference: RGUHS PG Thesis : 2017-2018, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 0(NA), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
patients fulfilling diagnostic criteria
patients fir for swedana |
|
| ExclusionCriteria |
| Details |
patients with systemic illness which will interfere with the study
all connective tissue disorder other than osteoarthritis |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
primary outcome will be assessed based on the following parameters
subjective parameters
pain, stiffness, visual pain analogue scale, womac-index of osteoarthritis
objective parameters
girth of joint measured by tape, range of movements |
0th day, 7th day and 14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| quality of life |
0th day and 14 day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
18/02/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
this is a randomised clinical study on medasaka patra upnaha and gulimavu patra upnaha in sandhigata vata with special reference to osteoarthritis of knee joint. in this study total 30 patients will be divided in two groups. in group A, medasaka patra upnaha will be done for 7 days and in group B, gulimavu patra upnaha will be done for 7 days for 15 patients to each group based on permuted block randomisation method. this study will be conducted in sri dharamsthala manjunatheshwara college of ayurveda, hospital and research centre, kuthpady, udupi. the primary outcome measures will be assessed based on the subjective and objective parameters. the secondary outcome measures will be assessed based on the quality of life scale. hence, this study is an effort to prove the efficacy of medasaka patra upnaha and gulimavu patra upnaha in sandhigata vata with special reference to osteoarthritis of knee joint. |