| CTRI Number |
CTRI/2021/04/032734 [Registered on: 12/04/2021] Trial Registered Prospectively |
| Last Modified On: |
26/09/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To asses the vata treartment ON VATA DOSHA W.S.R TO knee joint pain-VATA |
|
Scientific Title of Study
|
A CLINICAL APPRAISAL OF EFFECT OF THE VATASYOPAKRAMA ON VATA DOSHA W.S.R TO JANU SANDHI -VATA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrVasudev Anandrao chate |
| Designation |
Associate proffesor |
| Affiliation |
government ayurveda medical college and hospital mysore |
| Address |
dept of Ayurveda Samhita & Siddhanta.
government Ayurveda medical college & hospital
new sayyaji rao road, vishweshwarayya circle
mysore
Mysore
KARNATAKA
570001
India |
| Phone |
9448150212 |
| Fax |
|
| Email |
vachate37@gamil.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr shreevathsa |
| Designation |
Head of the department and professor |
| Affiliation |
government ayurveda medical college and hospital mysore |
| Address |
dept of Ayurveda Samhita & Siddhanta.
government Ayurveda medical college & hospital
new sayyaji rao road, vishweshwarayya circle
mysore
Mysore
KARNATAKA
570001
India |
| Phone |
9449772701 |
| Fax |
|
| Email |
dr.shreevathsa@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrVasudev Anandrao chate |
| Designation |
Associate proffesor |
| Affiliation |
government ayurveda medical college and hospital mysore |
| Address |
dept of Ayurveda Samhita & Siddhanta.
government Ayurveda medical college & hospital
new sayyaji rao road, vishweshwarayya circle
mysore
Mysore
KARNATAKA
570001
India |
| Phone |
9448150212 |
| Fax |
|
| Email |
vachate37@gamil.com |
|
|
Source of Monetary or Material Support
|
| Rajiv gandhi university of health science karnataka |
|
|
Primary Sponsor
|
| Name |
Rajiv gandhi university of health science karnataka |
| Address |
Rajiv gandhi university of health science, karnataka
4th T block , jayanagara
bengaluru-560041
karnataka
india |
| Type of Sponsor |
Government funding agency |
|
|
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 VASUDEV ANAND RAO CAHTE |
Goverment Ayurveda medical college and Hospital, mysore |
Kayachikitsa department Room no 10.
new sayyaji rao raod.vishweshwrayya circle
mysore
Mysore
KARNATAKA |
9448150212
vachate37@gamil.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 01/EC-IRC-FR/2019-20 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R268||Other abnormalities of gait and mobility. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
kaala basti |
Deepana-pachana-ajamodadi choorna for three days
koshta-shuddi-gandharva hastadi taila on fourth day
kaala basti for 15 days
kaala basti
anuvasana basti with guggulu tiktaka grutha for 10 days
niruha with dashamula kshira-basti for 5 days
parihara kaala-30 days
pathya- as prescribed in classics ksheera grutha godhuma mamsarasa |
| Comparator Agent |
NO COMPARATOR AGENT |
NO COMPARATOR AGENT
SINGLE ARM STUDY |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patient fulfilling the diagnostic criteria of janu sandhigata vata
patients fit for administration of basti karma
|
|
| ExclusionCriteria |
| Details |
patients suffering from any other systemic illness
janu sandhivata with piitanubandhi and kaphanubandhi will excluded |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
quality life of patient will improve
pain in knee joints will reduce
restricted mobility of joints will improve
|
4weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Quality of life of patient will improve.
|
6month |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
20/04/2021 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
publication of article in the national/ international indexed journals/RGUHS journal |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
sandhivata is one of the vata vyadhi, which is described as a separate clinical entity caused mainly due to dushti of vata, meda asthi, and majjs. the main sign and symptoms of sandhivata includes ; pain, swelling stifness, crepitus , pain on flexion and extension of the affected joint and tendreness, which are due to the vitiation of vata dosha. it is one such disease which causes so much suffering for a long period to the top in the list of chronic disease.
chikitsa of sandhigata vata is mainly vatasyopakrama i.e. snehana, swedana basti and vatahara aushadhi along with vatahara vihara. for sandhigata vata janu basti and nadi sweda are advised as a snehana and swedana purpose and any vatahara dravya basti is indicated because it plays important role in eradication of vata dosha, this is why basti is said to be the ardha chikitsa and sometime sarva chikitsa. for complete treatment shamanaushadi should be given fallowed by shodhana . in this disease vatahara dravyas like shatavari ashwagandha laksha etc are indicated
this work has been undertaken to evaluate the role and effect of vatasyopakrama on vata dosha in janu sandhigata vata |