| CTRI Number |
CTRI/2025/08/092686 [Registered on: 08/08/2025] Trial Registered Prospectively |
| Last Modified On: |
07/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [upanaha to janu sandhi] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
local application for osteoarthritis |
|
Scientific Title of Study
|
A Randomized controlled clinical study to evaluate the efficacy of shigru upanaha sweda in janusandhigatavata |
| 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 Arpitha K |
| Designation |
PG scholar |
| Affiliation |
Alvas Ayurveda Medical College and Hospital,Vidyagiri,Moodbidri |
| Address |
Department of Panchakarma Alvas Ayurveda Medical College and Hospital,Vidyagiri,Moodbidri Dakshina kannada, karnataka
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8660547484 |
| Fax |
|
| Email |
arpithak166@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Asundi Vijaylaxmi |
| Designation |
Professor |
| Affiliation |
Alvas Ayurveda Medical College and Hospital,Vidyagiri,Moodbidri |
| Address |
Department of Panchakarma Alvas Ayurveda Medical College and Hospital,Vidyagiri,Moodbidri Dakshina kannada, karnataka
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9995199733 |
| Fax |
|
| Email |
drvijaya121@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Asundi Vijaylaxmi |
| Designation |
Professor |
| Affiliation |
Alvas Ayurveda Medical College and Hospital,Vidyagiri,Moodbidri |
| Address |
Department of Panchakarma Alvas Ayurveda Medical College and Hospital,Vidyagiri,Moodbidri Dakshina kannada, karnataka
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9995199733 |
| Fax |
|
| Email |
drvijaya121@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Arpitha k |
| Address |
Alvas ayurveda medical college and hospital ,Moodbidri, Dakshina kannada,India |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| DrArpithaK |
Alvas ayurveda medical college and hospital |
Alvas ayurveda medical college and hospital
Dakshina Kannada
KARNATAKA |
0866 054 7484
arpithak166@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional clinical ethics committee Alvas Ayurveda Medical College,Vidyagiri,Moodbidri,Karnataka |
Approved |
| Institutional clinical ethics committee Alvas Ayurveda Medical College,Vidyagiri,Moodbidri,Karnataka |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: atasi churna, Reference: bhavprakash niganthu 66-67, dhanya varga, Route: Topical, Dosage Form: Lepa Churna, Dose: 150(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: shigru churna, Reference: charaka sutra 4/13, Route: Topical, Dosage Form: Lepa Churna, Dose: 150(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients fulfilling diagnostic criteria with or without swelling
Patients diagnosed on the basis of classical symptoms of JanuSandhigatavata
Patients between 20 to 70 years irrespective of gender will be considered
Patients who are fit for Upanaha Sweda |
|
| ExclusionCriteria |
| Details |
Patients having symptoms of Vatarakta Amavata
Patient having history of Amavata
Patients having symptoms or being diagnosed as any arthirits other than osteoarthritis
Patients with acute traumatic injury to the knees
Congenital bony deformity of knee joint |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Shigru upanaha Sweda in JanuSandhigatavata. |
0th day,8th day,15th day,22nd day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of Shigru Upanaha Sweda and Atasi Upanaha Sweda in
Janusandhigatavata |
0th day,8th day,15th day,22nd day |
|
|
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)
|
01/09/2025 |
| 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="1"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
- In Charaka Samhita and Ashtanga Sangraha, Shigru is mentioned under Swedopaga Dashemani . Shigru is very common and well known plant and widely cultivated.
- Shigru as swedopaga dravya in Janusandhigata Vata is not explored and it is cost effective. Studies shows that Shigru has 36 natural antiinflammatory agents
- Many studies are done on internal administration and external application of shigru in various vatavyadhi and has provided significant results. Hence, this study aims to evaluate the efficacy of Shigru Upanaha Sweda with Atasi Upanaha Sweda in Janusandhigata Vata.
- This study is randomized controlled clinical trial with comparitive standard procedure atasi upanaha sveda and interventional procedure shigru upanaha sveda
- This study is conducted on patients diagnosed with janusandhigatavata belongs to age group 20-70years who gives written consent for undergoing clinical study.
- Intervention period of study is 7 days. assessment will be done on 0thday,8th day,15thday,22nd day. total duration of the study is 22 days.
- Hypothesis
H0 – There is neither statistically significant difference between the efficacy of Shigru Upanaha Sweda and Atasi Upanaha Sweda in Janusandhigatavata NOR Shigru Upanaha Sweda has statistically significant effect over Atasi Upanaha Sweda in JanuSandhigatavata.
H1- There is statistically significant difference between the efficacy of Shigru Upanaha Sweda and Atasi Upanaha Sweda in Janusandhigatavata with Shigru Upanaha Sweda having significant effect over Atasi Upanaha Sweda in Janusandhigatavata.
|