| CTRI Number |
CTRI/2021/11/037709 [Registered on: 01/11/2021] Trial Registered Prospectively |
| Last Modified On: |
28/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [JANUBASTI] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
JANUBASTI( retention of medicated oil on knee joint ) ON ANTERIOR AND POSTERIOR ASPECT IN KNEEJOINT PAIN USING MURCHITA TILA TAILA
|
|
Scientific Title of Study
|
A RANDOMIZED COMPARITIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF JANUBASTI ON ANTERIOR ASPECT AND POSTERIOR ASPECT WITH MURCHITA TILATAILA IN JANUSANDHGATA VATA
|
| Trial Acronym |
JBSV |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr SHUBANTHJAIN MB |
| Designation |
PG Scholar (PANCHAKARMA) |
| Affiliation |
Sidramappa Danigond Memorial Trusts Ayurvedic Medical College and Research Centre |
| Address |
Department of Panchakarma ground floor Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduation Centre and Padma Ayurvedic Hospital Research Centre Sidhanth Nagar Terdal
Department of Panchakarma ground floor Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduation Centre and Padma Ayurvedic Hospital Research Centre Sidhanth Nagar Terdal
Bagalkot
KARNATAKA
587315
India |
| Phone |
8618374868 |
| Fax |
|
| Email |
shubanthjain@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Guralingappa Kalawwa Ankad |
| Designation |
Associate Professor |
| Affiliation |
Sidramappa Danigond Memorial Trusts Ayurvedic Medical College and Research Centre |
| Address |
Department of Panchakarma ground floor Sidramappa Danigond
Memorial Trusts Ayurvedic Medical College Post Graduation Centre
and Padma Ayurvedic Hospital Research Centre Sidhanth Nagar
Terdal
Department of Panchakarma ground floor Sidramappa Danigond
Memorial Trusts Ayurvedic Medical College Post Graduation Centre and Padma Ayurvedic Hospital Research Centre Sidhanth Nagar
Terdal
Bagalkot
KARNATAKA
58315
India |
| Phone |
9482365544 |
| Fax |
|
| Email |
drguruankad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SHUBANTHJAIN MB |
| Designation |
PG Scholar (PANCHAKARMA) |
| Affiliation |
Sidramappa Danigond Memorial Trusts Ayurvedic Medical College and Research Centre |
| Address |
Department of Panchakarma ground floor Sidramappa Danigond
Memorial Trusts Ayurvedic Medical College Post Graduation Centre and Padma Ayurvedic Hospital Research Centre Sidhanth Nagar
Terdal
Department of Panchakarma ground floor Sidramappa Danigond
Memorial Trusts Ayurvedic Medical College Post Graduation Centre and Padma Ayurvedic Hospital Research Centre Sidhanth Nagar
Terdal
Bagalkot
KARNATAKA
587315
India |
| Phone |
861834868 |
| Fax |
|
| Email |
shubanthjain@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
Department of Panchakarma ground floor Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduation Centre and Padma Ayurvedic Hospital Research Centre Sidhanth Nagar Terdal Bagalkot KARNATAKA 587315 India
|
| Type of Sponsor |
Private 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 SHUBANTHJAIN MB |
SIDRAMAPPA DANIGOND MEMORIAL TRUSTS AYURVEDIC MEDICAL COLLEGE AND RESEARCH CENTRE |
OPD AND IPD of SIDRAMAPPA DANIGOND MEMORIAL TRUSTS AYURVEDIC MEDICAL COLLEGE POST GRADUATION CENTRE AND PADMA AYURVEDIC HOSPITAL RESEARCH CENTRE SIDHANTH NAGAR TERDAL Bagalkot KARNATAKA
Bagalkot
KARNATAKA |
8618374868
shubanthjain@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee SDM Trusts Ayurvedic Medical College Danigond Post Graduation centre |
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 | - | jAnu-bastiH, जानà¥-बसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: SRINIVAS G ACHARYA PANCHAKARMA ILLUSTRATED 2015 EDITION PAGE 261-262, Procedure details: GROUP-A: JANUBASTI WITH MURCHITA TILATAILA ON POSTERIOR ASPECT OF KNEE JOINT FOR 45 MINUTES. DURATION: 7DAYS )
(1) Medicine Name: Murchitatila taila, Reference: AYURVEDA FORMULARY OF INDIA PART1 PAGE 351, Route: Topical, Dosage Form: Taila, Dose: 500(ml), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | jAnu-bastiH, जानà¥-बसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: SRINIVAS G ACHARYA PANCHAKARMA ILLUSTRATED 2015 EDITION PAGE 261-262, Procedure details: GROUP-B: JANUBASTI WITH MURCHITA TILATAILA ON ANTERIOR ASPECT OF KNEE JOINT FOR 45 MINUTES
DURATION: 7DAYS )
(1) Medicine Name: Murchitatila taila, Reference: AYURVEDA FORMULARY OF INDIA PART1 PAGE 351, Route: Topical, Dosage Form: Taila, Dose: 500(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients having classical signs and symptoms of Sandhigata Vata, like Sandhi Shoola, Sandhi Shotha, Prasarana Akunchana Vedana, Sparshaasahatva, Sandhi Sputana, Sandhi Stamba.
2. Age group between 30 to 70 years of either gender irrespective of religion, socioeconomic status.
3. Patients willing to sign the consent form.
|
|
| ExclusionCriteria |
| Details |
1. Patients of Vatarakta, Amavata, Kroshtuksheersha.
2. Patients with systemic disorders such as DM, HTN.
3. Patients having history of surgical, acute traumatic, neoplastic, and infectious conditions of knee joints.
4. Lactating and Pregnant Women.
5. Low back ache with or without radiation to legs.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Subjective and objective parameter |
15 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To find the comparative efficacy of the treatments indifferent groups.
|
15 DAYS |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
09/11/2021 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
To be published after completion of the study |
|
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 Efficacy of Janubasti on
anterior and posterior aspect of kneejoint. A minimum of 40 subjects will be
selected Randomly by lottery method in which 20 subjects are allocated for Group-A
for the Posterior janubasti study and 20 subjects are allocated for Group-B for
the Anterior janubasti study. Assessment will be done on the basis of prepared
proforma including subjective and objective parameters with different scales Janubasti is a
kind of Bahya Snehayukta Sweda,
Samshamaniya Bahirparimarjana Chikitsa. Tilataila is a Vataghna, which counteracts Ruksha and Sheeta Guna of
Vata by its snigdha Guna and Ushna Virya. Ushna Virya of drug and procedural
warmth will reduce stiffness. Janubasti on anterior aspect can have anatomical,
physiological lacunae, uneven surface of anterior aspect can make Basti
constructed with dough to cover major surface area of skin leaving limited area
of skin to absorb the oil which is contrary to the posterior aspect. So here an
attempt will be made through a posterior Janubasti which may help to restore
functional disability, with cost effectiveness, hence a study is planned to
explore the role of Janubasti on posterior aspect in Janusandhigata Vata. |