| CTRI Number |
CTRI/2023/08/056090 [Registered on: 03/08/2023] Trial Registered Prospectively |
| Last Modified On: |
04/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Curative] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Effect of Therapeutic Heat Burn and Yograja Guggulu In Knee Pain |
|
Scientific Title of Study
|
A Comparative Study On Efficacy of Agnikarma And Yograja Guggulu In The Management Of Janu-Sandhigatavata 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 |
Garima Verma |
| Designation |
MD Scholar |
| Affiliation |
Shri Krishna Govt. Ayurvedic College and Hospital |
| Address |
PG Department of Shalya Tantra, Shri Krishna Govt. Ayurvedic College and Hospital, Sector 8, Umri Road, Kurukshetra, 136118, Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
7496001218 |
| Fax |
|
| Email |
garimaverma019@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Garima Verma |
| Designation |
MD Scholar |
| Affiliation |
Shri Krishna Govt. Ayurvedic College and Hospital |
| Address |
PG Department of Shalya Tantra, Shri Krishna Govt. Ayurvedic College and Hospital, Sector 8, Umri Road, Kurukshetra, 136118, Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
7496001218 |
| Fax |
|
| Email |
garimaverma019@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Garima Verma |
| Designation |
MD Scholar |
| Affiliation |
Shri Krishna Govt. Ayurvedic College and Hospital |
| Address |
PG Department of Shalya Tantra, Shri Krishna Govt. Ayurvedic College and Hospital, Sector 8, Umri Road, Kurukshetra, 136118, Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
7496001218 |
| Fax |
|
| Email |
garimaverma019@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Krishna Govt. Ayurvedic College and Hospital |
|
|
Primary Sponsor
|
| Name |
Shri Krishna Govt. Ayurvedic College and Hospital |
| Address |
Shri Krishna Govt. Ayurvedic College and Hospital, Sector 8, Umri Road, Kurukshetra, 136118, Haryana |
| Type of Sponsor |
Government medical college |
|
|
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 Rajender Singh |
Shri Krishna Govt. Ayurvedic College and Hospital, Sector 8, Umri Road, Kurukshetra, 136118, Haryana |
Room No. 104, PG Department of Shalya Tantra, Shri Krishna Govt. Ayurvedic College and Hospital, Sector 8, Umri Road, Kurukshetra, 136118, Haryana
Kurukshetra
HARYANA |
8708866794
drrajendersingh1346@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri Krishna Ayush University 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: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® Pradhan Karma | (Procedure Reference: Sushruta Samhita, Procedure details: Purva Karma
Snigdha Picchila Annapana (rice and curd) will be given prior to the procedure. The site of Agnikarma will be washed with distilled water and wiped with dry sterilized gauze. Panchadhatu Shalaka (Red Hot) Ghritakumari pulp, Haridra Churna kept ready for dressing.
Pradhana Karma
In Osteoarthritis of the knee joint, supine position will be adopted as it is comfortable to the patient. Irrespective of a specific site, Agnikarma will be done at maximum tender site affected at the knee )
(1) Medicine Name: Yograja Guggulu, Reference: Bhaishajya Ratnawali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: tds, Duration: 21 Days | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Yograja Guggulu, Reference: Bhaishajya Ratnawali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients between age group of 30-70 years suffering from classical sign and symptoms of sandhigatavata at knee joints. |
|
| ExclusionCriteria |
| Details |
Age below 30 years and above 70 years.
History of knee joint dislocation/fracture/any surgical procedure of knee joint.
Grade 4- large osteophytes, marked narrowing of joint spcae, severe sclerosis and definite deformity of bone ends.
Co-existence of lesions to knee joint.
Patients suffering from disease like uncontrolled D.M., Carcinoma, Psoriatic arthritis, Gout, S.L.E., Polymyalgia Rheumatica & Tuberculosis will be excluded.
Patients having pacemaker or angiography done.
Malignant and Immuno-compromised patients (AIDS), HBsAg.
Pregnant women and lactating mothers.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the comparative efficacy of Agnikarma & Yograja Guggulu in Janu-Sandhigatavata |
After 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the combined efficacy of Agnikarma & Yograja Guggulu in Janu-Sandhigatavata |
After 21 days |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
N/A |
|
Date of First Enrollment (India)
|
22/08/2023 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 Vriddhavastha, all Dhatus undergo Kshaya, thus leading to Vataprakopa and making individual prone to many diseases. Among them Sandhigata Vata stands top in the list.
Sandhigata Anila predominently affects major weight bearing joints of the body in which knee joint attains first priority. Comprehensive management of this condition in Ayurveda includes a judicious combination of external therapies (Bahya Chikitsa) and internal medication (Abhyantara Chikitsa). The Bahya Chikitsa include Janu Basti, Abhyanga (massage), Raktamokshana, Agnikarma (cautery), Basti (medicated enema), etc. Abhyantara Chikitsa include the internal medications in the form of Churna (powder of a single herb/combination of herbs), Kashaya (decoction), Vati (pills), etc. Need of the study is to evaluate the comparative efficacy of agnikarma and yograja guggulu both individually and in combination. |