| CTRI Number |
CTRI/2020/12/029741 [Registered on: 11/12/2020] Trial Registered Prospectively |
| Last Modified On: |
10/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Study The Effect of Panchaprasrutik Basti(Medicated Enema) in Patients having Sandhigata Vata specially for Janusandhi(Knee Osteoarthritis). |
|
Scientific Title of Study
|
Clinical Study on The Efficacy of Panchaprasrutik Basti in The Management of Sandhigata Vata with special reference to Janusandhi |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Krupali Panchal |
| Designation |
MD Scholar (Panchakarma) |
| Affiliation |
Dr D Y Patil College of Ayurved and Research Centre |
| Address |
OPD No9 Panchakarma Department Dr D Y Patil College of Ayurved and Research Centre Santtukaram nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8380082004 |
| Fax |
|
| Email |
krupalidpanchal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Mamata Nakade |
| Designation |
MD Phd (Kayachikitsa) |
| Affiliation |
Dr D Y Patil College of Ayurved and Research Centre |
| Address |
OPD No9 Panchakarma Department Dr D Y Patil College of Ayurved and Research Centre Santtukaram nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9850241887 |
| Fax |
|
| Email |
mamtaraut1966@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Mamata Nakade |
| Designation |
MD Phd (Kayachikitsa) |
| Affiliation |
Dr D Y Patil College of Ayurved and Research Centre |
| Address |
OPD No 9 Panchakarma Department Dr D Y Patil College of Ayurved and Research Centre Santtukaram nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9850241887 |
| Fax |
|
| Email |
mamtaraut1966@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil College of Ayurved and Research Centre, Sant tukaram nagar Pimpri Pune 411018 |
|
|
Primary Sponsor
|
| Name |
Dr Krupali Panchal |
| Address |
Dr D Y Patil College of Ayurved and Research Centre Santtukaram nagar Pimpri Pune |
| Type of Sponsor |
Other [Self] |
|
|
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 Krupali Panchal |
Dr D Y Patil Ayurved Hospital |
Room no 9, Panchakarma Department
Pune
MAHARASHTRA |
8380082004
krupalidpanchal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M170||Bilateral primary osteoarthritis of knee. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Panchaprsrutik Basti |
Medicated decoction (Panchaprasrutik basti) weighted 480ml made with cow milk, cow ghee, honey and sesame oil will be given as enema by anal route to 76 patients daily for 9 days |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients having symptoms like Vatapurna druti sparsh(Joint crepitus), Sandhishoola(Joint pain), Sandhishotha(Joint swelling), Aakunchanprasaranjanya Vedana(Joint restriction). |
|
| ExclusionCriteria |
| Details |
Patients having pther diseases like rheumatoid arthritis, gout, tubarcular knee joint.
Patients having history of fracture of knee joint, knee transplantation, psoriatic arthritis or any surgical history of knee joint. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Panchaprasrutik basti is effective in the management of Sandhigatavata with special reference to Janusandhi |
18 days study with 2 follow up (0,9,18 days) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in grades of sandhigatavata will be studied |
18 days study with 2 follow up (0,9,18 days) |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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 |
|
Date of First Enrollment (India)
|
20/12/2020 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Study the efficacy of Panchaprasrutik basti which is medicated decoction will be given as enema through anal route on 76 patients suffernig from Sandhigata vata (Osteoarthritis) of Janusandhi (knee joint). Purpose of this treatment is to nourish and stregthen thr knee joint. total 76 patients will be given basti for 9days. Total duration of the study is 18days (0, 9, 18days followup) |