| CTRI Number |
CTRI/2025/05/087531 [Registered on: 26/05/2025] Trial Registered Prospectively |
| Last Modified On: |
25/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare effectiveness of Yogaraja Guggulu Rasayana and Lashuna Rasayana in Knee pain relief in Osteoarthritis of Knee. |
|
Scientific Title of Study
|
A randomized comparative clinical study to evaluate the effect of Yogaraja Guggulu Rasayana and Lashuna Rasayana in Janu Bheda W.S.R to Osteoarthritis of the 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 Sanjana S Nadagouda |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda, Hospital and Research Centre,Kuthpady,Udupi |
| Address |
OPD 7, Department of Kayachikitsa, Sri Dharmasthala Manjunatheshwara College of Ayurveda, Hospital and Research Centre,Kuthpady,Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
9380863443 |
| Fax |
|
| Email |
sanjananadagouda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shailesh Y |
| Designation |
MD(AYU),Assistant professor, department of Kayachikitsa |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda, Hospital and Research Centre,Kuthpady,Udupi |
| Address |
OPD 7, Department of Kayachikitsa, Sri Dharmasthala Manjunatheshwara College of Ayurveda, Hospital and Research Centre,Kuthpady,Udupi.
Udupi
KARNATAKA
574118
India |
| Phone |
9481522560 |
| Fax |
|
| Email |
drshayayu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shailesh Y |
| Designation |
MD(AYU),Assistant professor, Department of Kayachikitsa |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda, Hospital and Research Centre,Kuthpady,Udupi |
| Address |
OPD 7,Department of Kayachikitsa,Sri Dharmasthala Manjunatheshwara College of Ayurveda, Hospital and Research Centre,Kuthpady,Udupi.
Udupi
KARNATAKA
574118
India |
| Phone |
9481522560 |
| Fax |
|
| Email |
drshayayu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pharmacy of Sri Dharmasthala Manjunatheshwara College of Ayurveda, Hospital and Research Centre,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 Sanjana S Nadagouda |
Sri Dharmasthala Manjunatheshwara College of Ayurveda, Hospital and Research Centre,Kuthpady,Udupi. |
OPD 7, Department of Kayachikitsa,Sri Dharmasthala Manjunatheshwara College of Ayurveda, Hospital and Research Centre,Kuthpady,Udupi
Udupi
KARNATAKA |
9380863443
sanjananadagouda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethial Committee, Sri Dharmasthala Manjunatheshwara College of Ayurveda, Hospital and Research Centre,Kuthpady,Udupi. |
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: JANUBEDAH (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Lashuna Rasayana, Reference: Astanga Hridaya Uttaratantra, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 6(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: milk), Additional Information: capsules of lashuna rasayna will be given | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Yogaraja Guggulu, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Guggulu , Dose: 3(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All participants fulfilling the diagnostic criteria from the age of 30 to 70 years
Participants willing to sign the informed consent form to participate in the research |
|
| ExclusionCriteria |
| Details |
Subjects suffering from illnesses like Rheumatoid Arthritis, Gouty Arthritis ,Systemic Lupus Erythematous, Fracture
Any other metabolic and auto Immune joint pathologies
Pregnant women and lactating women
Patients unfit for Guggulu or Lashuna intake |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment is done on 0th and 30th day
1)WOMAC index of Osteoarthritis
2)Pain Visual Analog Scale
3)Limitation of range of moments with the help of Goniometer
4)Functional ability
Time required to cover 30 meters in seconds
10 sit up time required
time taken to climb 10 steps |
Assessment will be done on the basis of Subjective and Objective criteria on 0 and 30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Gait
2)Swelling
3)Stiffness
4)Tenderness |
On 0TH & 30TH 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)
|
23/06/2025 |
| 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 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
|
This is a randomized
comparative clinical study to evaluate the effectiveness of group A- Yogaraja
Guggulu Rasayana which will be given for 30 days in the dosage of 6 tablets OD
of 450mg after Koshta Shodhana of 1 day with Eranda Taila and Shunti Kashaya. Group
B- Lashuna Rasayana for 30 days in dosage of 12 capsules of 500mg OD with milk
after 1 day of Koshta Shodhana with Eranda Taila and Shunti Kashaya. The group
B subjects after 30 days of medicine will be given 20gm of Trivrut Lehya with
milk for 1 day, morning on empty stomach for Shodhana. There will be 15
subjects in each group and selection will be based on permuted block
randomization method. The study will be conducted in Sri Dharmasthala
Manjunatheshwara college of Ayurveda,Hospital and Research Centre,Kuthpady,Udupi.
The primary outcomes are WOMAC scale for Osteoarthritis, Pain Visual Analog Scale,
range of motion and functional ability. Secondary outcome measures are gait, swelling,
stiffness and tenderness. The assessment will be done on 0th day and 30th day.
|