| CTRI Number |
CTRI/2024/09/073228 [Registered on: 02/09/2024] Trial Registered Prospectively |
| Last Modified On: |
29/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Study To Compare The Effect Of Bala Taila And Ketakyadi Taila Orally With Kottamchukkadi Taila Filling illing On Knee Joint The Management Of Janusadhigata Vata Vis A Vis Osteoarthritis Of Knee Jount |
|
Scientific Title of Study
|
A Comparative Clinical Study To Evaluate The Effect Of Bala Taila And Ketakyadi Taila Orally With Kottamchukkadi Taila Janu Basti In The Management Of Janusadhigata Vata Vis A Vis Osteoarthritis Of Knee Joint |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr TEJASWINI HIREMATH |
| Designation |
PG SCHOLAR |
| Affiliation |
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Research Centre |
| Address |
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital
And Research Centre Department of Kayachikitsa room number 2
No 10 Pipeline road RPC Layout Vijayanagar 2nd stage Bangalore
560104
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital
And Research Centre Department of Kayachikitsa room number 2
No 10 Pipeline road RPC Layout Vijayanagar 2nd stage Bangalore
560104
Bangalore
KARNATAKA
560104
India |
| Phone |
7411011817 |
| Fax |
|
| Email |
tejush82@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MANJUNATH ADIGA |
| Designation |
PROFESSOR |
| Affiliation |
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Research Centre |
| Address |
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital
And Research Centre Department of Kayachikitsa room number 2
No 10 Pipeline road RPC Layout Vijayanagar 2nd stage Bangalore
560104
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital
And Research Centre Department of Kayachikitsa room number 2
No 10 Pipeline road RPC Layout Vijayanagar 2nd stage Bangalore
560104
Bangalore
KARNATAKA
560104
India |
| Phone |
9035715798 |
| Fax |
|
| Email |
adiga.manjunatha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MANJUNATH ADIGA |
| Designation |
PROFESSOR |
| Affiliation |
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Research Centre |
| Address |
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital
And Research Centre Department of Kayachikitsa room number 2
No 10 Pipeline road RPC Layout Vijayanagar 2nd stage Bangalore
560104
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital
And Research Centre Department of Kayachikitsa room number 2
No 10 Pipeline road RPC Layout Vijayanagar 2nd stage Bangalore
560104
Bangalore
KARNATAKA
560104
India |
| Phone |
9035715798 |
| Fax |
|
| Email |
adiga.manjunatha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital
And Research Centre Department of Kayachikitsa room number 2
No 10 Pipeline road RPC Layout Vijayanagar 2nd stage Bangalore
560104 |
|
|
Primary Sponsor
|
| Name |
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Research Centre Bangalore |
| Address |
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital
And Research Centre Department of Kayachikitsa room number 2
No 10 Pipeline road RPC Layout Vijayanagar 2nd stage Bangalore
560104 |
| 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 Kiran M Goud |
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Research Centre Bangalore |
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital
And Research Centre Department of Kayachikitsa room number 2
No 10 Pipeline road RPC Layout Vijayanagar 2nd stage Bangalore
560104
Bangalore
KARNATAKA |
9845109556
kiranmgoud@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SKAMCHANDRC |
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 | Drug | Classical | | (1) Medicine Name: BALA TAILA, Reference: Astanga hrudaya chikitsa Sthana 21st chapter verse 73-82. Pg. No-727&728., Route: Oral, Dosage Form: Taila, Dose: 18(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: 75ml of warm water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: KETAKYADI TAILA, Reference: Chakradatta Chikitsa Sangraha , Route: Oral, Dosage Form: Taila, Dose: 18(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: 75ml of warm water), Additional Information: - | | 3 | Comparator Arm | Procedure | - | JanuBasti | (Procedure Reference: Saharayoga , Procedure details: Janu basti with Kottamchukkadi taila for 15days to affect knee joint )
(1) Medicine Name: Kottamchukkadi taila , Reference: Saharayoga , Route: Topical, Dosage Form: Taila, Dose: 100(ml), Frequency: od, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with clinical features of Janu Sandhigata Vata.
Patients with the clinical features of Osteoarthritis Knee joint.
Patients belonging to the age group of 40 - 70 years irrespective of gender |
|
| ExclusionCriteria |
| Details |
Post-surgical and prosthetic knee joints.
Subjects with history of recent trauma and fracture.
Subjects suffering from any other systemic disorders which interfere with the course of intervention |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A Clinical Study To Compare The Effect Of Bala Taila And Ketakyadi Taila Orally With Kottamchukkadi Taila Janu Basti In The Management Of Janusadhigata Vata Vis A Vis Osteoarthritis Of Knee Jount |
1 year 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NOT APPLICABLE |
|
|
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 |
|
Date of First Enrollment (India)
|
15/09/2024 |
| 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="3"
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
|
Bala Taila is mentioned in Ashtanga Hrudaya,Vatavyadhi Chikitsa.In this most of the ingredients are Madhura Rasa, Ushna Virya ,Snigdha Guna, Madhura Vipaka is effective in balances the Vata dosha and has anti-inflammatory, analgesic, antioxidants, and immune booster properties. In Janu Sandhigata Vata, the affected limb will get nourished and gain strength, the vital activities of body also strengthened and restored. Ketakyadi Taila is mentioned in chradatta Vatavyadhi chikitsa,The most of the ingredients having Madhura rasa , Laghu, Snigdha Guna and Madhura vipaka which is opposite to the guna of vata and vatahara property. Balya, shothohara, brimhana,anti-inflammatory,analgesic properties. Janu Basti with Kottamchukkadi tail mentioned in Sahasarayoga is selected for Bahya snehana in the form of Janu Basti it is Snigdha Swedana in the management of Janusandhigata Vata. |