| CTRI Number |
CTRI/2022/01/039401 [Registered on: 13/01/2022] Trial Registered Prospectively |
| Last Modified On: |
18/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
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Drug
Ayurveda
Other (Specify) [Panchakarma] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
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Public Title of Study
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EFFICACY OF JANU PICHU, BRIMHANA SNEHAPANA AND MATRA BASTI WITH KSHEERABALA TAILA IN THE MANAGEMENT OF SANDHIGAT VATA (OSTEOARTHRITIS ); A COMPARATIVE CLINICAL STUDY
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Scientific Title of Study
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EFFICACY OF JANU PICHU, BRIMHANA SNEHAPANA AND MATRA BASTI WITH KSHEERABALA TAILA IN THE MANAGEMENT OF SANDHIGAT VATA (OSTEOARTHRITIS ); A COMPARATIVE CLINICAL STUDY
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| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Harshali Shende |
| Designation |
PG Scholar |
| Affiliation |
All India Institute of Ayurveda, New Delhi 110076 |
| Address |
OPD No.6, Ground floor ,Hospital Block,All India Institute of Ayurveda Gautampuri, Sarita Vihar,New Delhi 110076
New Delhi
DELHI
110076
India |
| Phone |
7558669264 |
| Fax |
|
| Email |
harshu.shende96@gmail.com |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Santosh Kumar Bhatted |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Ayurveda, New Delhi 110076 |
| Address |
Room no.703,Department of Panchakarma, Academic block,All India Institute of Ayurveda Gautampuri, Sarita Vihar,New Delhi 110076
New Delhi
DELHI
110076
India |
| Phone |
9414048459 |
| Fax |
|
| Email |
santoshbhatted@rediffmail.com |
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Details of Contact Person
Public Query
|
| Name |
Dr Anandaraman P V |
| Designation |
Professor and HOD |
| Affiliation |
All India Institute of Ayurveda, New Delhi 110076 |
| Address |
Room no.704,Department of Panchakarma, Academic block,All India Institute of Ayurveda Gautampuri, Sarita Vihar,New Delhi 110076
New Delhi
DELHI
110076
India |
| Phone |
9495130595 |
| Fax |
|
| Email |
dr.ananthramsharma@gmail.com |
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Source of Monetary or Material Support
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| All India Institute Of Ayurveda |
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Primary Sponsor
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| Name |
All India Institute of Ayurveda |
| Address |
All India Institute of Ayurveda Gautampuri, Sarita Vihar, New Delhi 110076 |
| Type of Sponsor |
Research institution and hospital |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Harshali Shende |
All India Institute of Ayurveda |
OPD No.06, Department of Panchakarma, Ground floor, All India Institute of Ayurveda, Gautampuri, Sarita Vihar ,New Delhi-110076
South West
DELHI |
7558669264
harshu.shende96@gmail.com |
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M170||Bilateral primary osteoarthritis of knee. Ayurveda Condition: Sandhigata Vata, |
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Intervention / Comparator Agent
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| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | Matra Basti | (Procedure Reference: Charaka Siddhisthana, Procedure details: Medicated enema will be given in a dose of 60 ml in left lateral position ( Right leg Flexed and left leg extended) after that gentle tap will be given on buttock region .))
(1) Medicine Name: Ksheerabala Tailam, Reference: Ashtanga Hrudayama 22, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 14 Days | | 2 | Intervention Arm | Procedure | - | Janu Pichu | (Procedure Reference: Ashtanga Hrudayam Sutrasthana 22, Procedure details: Pichu will be made up of cotton pad (4*4)
Ksheerabala taila will be heated in a hot water bath.
Then Cotton Gauze (Pichu) will be dipped in a warm oil.
It will be placed on the knee joint.
The medicine in the initial Pichu will be replaced with the heated oil by another Pichu of same size every 10 minutes.
In case of Vataja disorders the Dravyas should be retained for ten thousand Matra Kala. (which is approx. 43 min.) Hence the procedure will be performed for 40 minutes.
After 40 min. th)
(1) Medicine Name: Ksheerabala Tailam, Reference: Ashtanga Hrudaya,chikitsasthana 22, Route: Topical, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Duration: 14 Days | | 3 | Intervention Arm | Procedure | - | Brimhana Snehapana | (Procedure Reference: Charaka Sutrasthana 13, Procedure details: Warm 25 ml Ksheerabala Tailam will be given to patient once daily )
(1) Medicine Name: Ksheerabala Tailam, Reference: Ashtanga Hrudayama chikitsasthana 22, Route: Oral, Dosage Form: Taila, Dose: 25(ml), Frequency: od, Duration: 28 Days |
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Inclusion Criteria
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| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Age between 40-70 yrs.
2.Chronicity: 6 months to 10 yrs.
3. Gender :Both.
4. Socio-economic status: All
5.Degenerative changes in X- ray of knee joint (Grade 1, 2, 3)
6.Subjects fit for Basti Karma and Brimhana Snehapana
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| ExclusionCriteria |
| Details |
1.Subjects with Diabetes Mellitus
2.Subjects diagnosed with Rheumatoid Arthritis.
3.Subjects with infective arthritis.
4.Subjects unfit for Basti karma, Brimhana Snehapana.
5.Grade 4 in X ray finding of Knee Joint.
6.Subjects having BMI more than 30
7.Traumatic cases like fractures of Knee Joint.
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Method of Generating Random Sequence
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Random Number Table |
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Method of Concealment
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Not Applicable |
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Blinding/Masking
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Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
1.Reduction in Pain
2.Improvement in Range of Motion
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(DAY-0)(DAY-13)(DAY-27)(DAY-34)(DAY-64) |
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Secondary Outcome
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| Outcome |
TimePoints |
Reduction in symptoms like swelling, tenderness, crepitation, improvement in range of motion.
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(DAY-0)(DAY-13)(DAY-27) (DAY-34)(DAY-64) |
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Target Sample Size
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Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
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Phase of Trial
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Phase 2/ Phase 3 |
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Date of First Enrollment (India)
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01/02/2022 |
| Date of Study Completion (India) |
04/09/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
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Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
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Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
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Publication Details
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The outcomes of the study will be communicated to peer reviewd journals for wider dissemination |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
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INTRODUCTION: Osteoarthritis is the most common type of arthritis in both developed and developing countries. It is a chronic, progressive musculoskeletal disorder characterized by gradual loss of cartilage in joints which results in bones rubbing together and creating stiffness, pain and impair movements. Osteoarthritis is strongly associated with ageing and is major cause of pain and disability in older people.The overall prevalence of knee Osteoarthritis was found to be 28.7% in India. Sandhigatvata stands top among all Vatavyadhi in the list. The affliction of Sandhis (joints) by Prakupita Vata is the chief phenomena in Samprapti (aetiopathogenesis) of Sandhigatvata. Osteoarthritis of knee joint can be compared with Janu Sandhigat Vata due to its clinical appearance and pathogenesis. Janu Sandhigat Vata is one among the most common Sandhigat Vata Vyadhi. This disease affects the knee joint which is one among the most important weight bearing joint in the body. In Ayurveda, Snehana (Oleation), Swedana (Sudation), Mridu Shodhana (mild cleansing treatment) are the prime modalities of treatment in the management of Vatavyadhi in general. Snehana and Swedana are specifically indicated for the treatment of Sandhigat Vata. Ksheerabala Taila has been mentioned by almost all ancient ayurvedic texts with different names and is a vatahara taila. Hence this study is planned to evaluate the effect of Janu Pichu, Brimhana Snehapana and Matra basti with ksheerabala taila in relieving pain in the patients of osteoarthritis of knee joint.
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