| CTRI Number |
CTRI/2018/09/015677 [Registered on: 11/09/2018] Trial Registered Prospectively |
| Last Modified On: |
10/09/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Other |
|
Public Title of Study
|
A comparative study of using 2 different taila by giving a matra basti in the management of janusandhigata vata |
|
Scientific Title of Study
|
A comparative clinical study of effect of matra basti using plain tila taila and karpasathi kulatha siddha taila in the management of janusandhigata vata. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aditi nilakhe |
| Designation |
MD student |
| Affiliation |
Sterling and ayurvedic hospital akurdi pune |
| Address |
College of ayurved and research center
Department-panchakarma
Room no-216
Akurdi pune
Pune
MAHARASHTRA
411044
India |
| Phone |
7387710797 |
| Fax |
|
| Email |
aditin738@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr pournima daware |
| Designation |
Lecturer |
| Affiliation |
Sterling and ayurvedic hospital akurdi pune |
| Address |
College of ayurved and research centre pune
Department-panchakarma
Room no-216
Akurdi pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9762561699 |
| Fax |
|
| Email |
rikibepournima@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aditi nilakhe |
| Designation |
MD student |
| Affiliation |
Panchakarma department |
| Address |
College of ayurved and research centre
Department-panchakarma
Room no-216
Sterling and ayurvedic hospital akurdi pune
Pune
MAHARASHTRA
411044
India |
| Phone |
7387710797 |
| Fax |
|
| Email |
aditin738@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sterling and ayurvedic hospital akurdi pune |
|
|
Primary Sponsor
|
| Name |
Sterling and ayurvedic hospital |
| Address |
Akurdi bhel chowk pune |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Aditi nilakhe |
Sterling and ayurvedic hospital |
Bhel chowk akurdi pune
Department-panchakarma
Room no-412
Pune
MAHARASHTRA |
7387710797
aditin738@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Istitutional 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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Matra basti using karpasasthi kulatha siddha taila |
To compare with matra basti given with plain tila taila which will be more effective in janusandhigata vata
Dose-60 ml duration-8 days
Frequency- once a day |
| Intervention |
Matra basti using plain tila taila |
Comparative study of matra basti using plain tila taila and karpasasthi kulatha siddha taila which gives more effect in management ofjanusandhigata
vata.
Dose-60 mla duration-8 days frequency -once a day |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Pateint having sign and symptoms of
Janusandhi shoola (pain)
Sandhi shotha(swelling)
Vata purna druti sparsh(crepitus)
Prasaran akunchan swedana( pain extension flexion |
|
| ExclusionCriteria |
| Details |
Patient having other joint deformities
Neoplasm
Fracture of knee joint
Permenent joint damage
Known cases of HIV DM pulmonary TB paralysis pregnency |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 To study the efficacy of matra basti given with palin tila taila in the management of janusandhi gata vata
2 To study the effect of matra basti given with a karpasasthi kulatha siddha taila in the management of janusandhi gata vata |
Symtoms should be noted in 0 3rd nd 8th day of treament |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of matra basti given with plain tila taila and karpasasthi kulatha siddha taila in the management of janusandhigata vat |
To observe the adverse effect if any |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
19/09/2018 |
| 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="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
I will going to see the effect of two tails which one gives the best effect in janusandhigata vata by giving 8 days matra basti |