| CTRI Number |
CTRI/2023/03/050165 [Registered on: 01/03/2023] Trial Registered Prospectively |
| Last Modified On: |
28/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Para-Surgical] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Study on Agni Karma (Heat Therapy) with Guda (Jaggery) and Panchdhatu Shalaka (Metallic Instrument) in the management of Janu Sandhigat Vata (Pain in Knee Joint and Restricted Movements). |
|
Scientific Title of Study
|
A Comparative Study on Agni Karma with Guda and Panchdhatu Shalaka in the management of Janu Sandhigat Vata w.s.r. to Osteo Arthritis of Knee Joint |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neeraj Kumar |
| Designation |
PG Scholar |
| Affiliation |
shri Krishna government Ayurvedic College and Hospital Kurukshetra |
| Address |
room no 14, OPD shalya tantra, Shri Krishna Government Ayurvedic College and Hospital Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
8307615356 |
| Fax |
|
| Email |
indian.verma123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Devendra khurana |
| Designation |
professor |
| Affiliation |
hri Krishna government Ayurvedic College and Hospital Kurukshetra |
| Address |
room no 103,Shri Krishna government Ayurvedic College and Hospital Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9416337325 |
| Fax |
|
| Email |
dr.devendrakhurana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Neeraj Kumar |
| Designation |
pg scholar |
| Affiliation |
hri Krishna government Ayurvedic College and Hospital Kurukshetra |
| Address |
room no.14, shalya tantra opd, Shri Krishna government Ayurvedic College and Hospital Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
8813962394 |
| Fax |
|
| Email |
indian.verma123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Krishna AYUSH University |
|
|
Primary Sponsor
|
| Name |
Shri Krishna AYUSH University |
| Address |
Shri Krishna AYUSH University, Umri road, sec.8, Kurukshetra Haryana |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Neeraj Kumar |
Room no.14 , opd of shalya tantra , shri krishna govt. Ayurvedic hospital |
shri krishna govt. ayurvedic hospital, Umri road. Kurukshetra
Kurukshetra
HARYANA |
8813962394
indian.verma123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Research committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Su. S. 12/4, Procedure details: Agni Karma will be done on 0,7,14,21 days with Guda)
| | 2 | Comparator Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: su.su.12/4, Procedure details: Agni karma will be done on 0,7,14,21 days with pancha dhatu shalaka)
|
|
|
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Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient having sign & symptoms as explained in Ayurvedic Classical Texts and modern text books related to the topic.
Patient between the age of 40-70 years
Patients of both sex.
Patients who will be willing for the treatment.
|
|
| ExclusionCriteria |
| Details |
Pregnant Women
Patients with Amavata & Vatarakta
Janu Sandighat Vata due to Abhighata (before 6 months).
Patient with condition mentioned under contra indication for Agnikarma in Sushruta Samhita .
Patients with systemic diseases like uncontrolled diabetes , Uncontorlled Hypertension, Patients with major disorder like neoplastic conditions of knee.
T.B.Knee Joint.
Patient with condition Haemarthrosis Pyoarthorosis.
Patient undergoing other modalities of treatment for Janu Sandhigata Vata.
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
On-site computer system |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| pain |
baseline,1 week,2week,3week |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Tenderness , Swelling, Range of movement , crepitus |
baseline,1 week,2week,3week |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
05/03/2023 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
not yet |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Osteoarthritis knee is a common troublesome problem. Although the disease is
not fatal but its attacks and duration of pain makes the life of patient and
miserable. The contemporary system of medicine mainly aims at pain relief,
prevention of recurrence and improving functions. Analgesics Anti
inflammatory and are the drug of choice. Surgery is performed rarely.
Unfortunately the analgesic taken through mouth have too many side effects
particularly in prolonged uses like gastritis, Gastric ulcer etc. In this modern
world patients wants quick and sustainable relief from pain. And Agnikarma
can be a very good answer for this. It is an OPD based procedure, easy to
perform , doesn’t require big setup and can be used as therapeutic and
Adjuvant therapy.
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