| CTRI Number |
CTRI/2021/03/032318 [Registered on: 25/03/2021] Trial Registered Prospectively |
| Last Modified On: |
16/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic management of knee joint arthritis with the help of different types of sudation therapy and panchatikta ghrita guggulu vati. |
|
Scientific Title of Study
|
Efficacy of Patra Pinda Sweda, Nadi Sweda and Upnaha Sweda followed by Panchatikta Ghrita Gugglu (Shamana) in the management of Janu Sandhigata Vata w. s. r. to Knee Arthritis : An Open Labelled Randomised Comparative Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ATUL JOSHI |
| Designation |
PhD 1st year |
| Affiliation |
Institue of Teaching and Research in Ayurveda |
| Address |
4th floor department of panchkarma IPGTandRA Jamnagar
Jamnagar
GUJARAT
361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
9106736995 |
| Fax |
|
| Email |
dratuljoshi1992@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Anup Thakar |
| Designation |
Director ITRA , HOD Department of Panchakarma |
| Affiliation |
Institue of Teaching and Research in Ayurveda |
| Address |
4th floor department of panchkarma IPGTandRA Jamnagar
Jamnagar
GUJARAT
361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
9427776660 |
| Fax |
|
| Email |
anup_thakar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Anup Thakar |
| Designation |
Director ITRA , HOD Department of Panchakarma |
| Affiliation |
Institue of Teaching and Research in Ayurveda |
| Address |
4th floor department of panchkarma IPGTandRA Jamnagar
Jamnagar
GUJARAT
361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
9427776660 |
| Fax |
|
| Email |
anup_thakar@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ITRA GAU JAMNAGAR |
| Address |
JAMNAGAR |
| 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 |
| Dr Atul Joshi |
ITRA |
OPD NO. 14, Deparatment of Panchakarma, Gujarat Ayurveda University
Jamnagar
Jamnagar
GUJARAT |
9106736995
dratuljoshi1992@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:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: VATAVYADHIH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nadi sweda, Panchatikta ghrita guggulu |
Nadi sweda for 21 days followed by Panchatikta ghrita guggulu 3 vati (500 mg) twice a day for 21 days |
| Intervention |
Patra pinda sweda, Panchatikta ghrita guggulu |
Patra pinda sweda for 21 days followed by Panchatikta ghrita guggulu 3 vati (500 mg) twice a day for 21 days |
| Comparator Agent |
Upanaha sweda, Panchatikta ghrita guggulu |
Upanaha sweda for 21 days followed by Panchatikta ghrita guggulu 3 vati (500 mg) twice a day for 21 days |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with the classical signs and symptoms of Janu Sandhigata Vata
(OA) like Sandhishoola, Sandhishotha, Akunchanprassarnevedana etc.
Patients of either sex age between 30 - 70 years will be included.
Patients suitable for Swedana Karma.
Patients having BMI less than 30 shall be included.
Washout Period: Patient might be taking any other medicine for disease will be advised for washout period of 15 Days.
|
|
| ExclusionCriteria |
| Details |
Patients below 30 years and above 70 years of age.
Patients not suitable for Swedana Karma.
Patients suffering from Gout, Rheumatoid arthritis, Systemic Lupus Erythematous (SLE), known cases of Bone TB, Psoriatic arthritis and other serious systemic disorders will be excluded.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in sign and symptoms of Janusandhigata vata (knee joint arthritis) |
6 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improves quality of life of the person,after 6 week treatment |
Improves quality of life of the person,after 6 week treatment |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "99"
Final Enrollment numbers achieved (India)="99" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2021 |
| Date of Study Completion (India) |
28/09/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The trial is open labelled randomized clinical trial to evaluate the efficacy of patra pinda sweda, nadi sweda and upanaha sweda followed by panchatikta ghrita guggulu in the management of janusandigata vata (knee joint arthritis). Total 90 patients will be enrolled in the study. Selected patients will be divided into 3 groups on the basis of computer generated randomization. In this study in group A patra pinda sweda for 21 days followed by panchatikta ghrita guggulu 3 vati (500 mg) twice a day will be given to the patients, in group B nadi sweda for 21 days followed by panchatikta ghrita guggulu 3 vati (500 mg) twice a day will be given to the patients and in group C upanaha sweda for 21 days followed by panchatikta ghrita guggulu 3 vati (500 mg) twice a day will be given to the patients. Follow up will be carried out for 1 month at the interval of 15 days. |