| CTRI Number |
CTRI/2023/11/059646 [Registered on: 08/11/2023] Trial Registered Prospectively |
| Last Modified On: |
01/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
In this study one group of Patientof Janusandhigata Vata will be treated with A Kukkutanda Pinda Sweda with Matra Basti of Tila Taila and other group will be treated with Matra Basti of Tila Tail |
|
Scientific Title of Study
|
A Comparative Clinical Study to evaluate add on effect of Kukkutanda Pinda Sweda with Matra Basti of Tila Taila in 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 Prerna Vishvasrao Gadhe |
| Designation |
M.D. SCHOLAR PANCHKARMA |
| Affiliation |
SUMATIBHAI SHAH AYURVEDA MAHAVIDYALAYA |
| Address |
Sumitibhai shah Ayurveda Mahavidyalaya, Malwadi, Hadpsar OPD No. 6, Department of Panchkarma, Sane Guruji Arogya Kendra, Hadpsar, Malwadi, Pune 411028
Maharashtra, India
Sumitibhai shah Ayurveda Mahavidyalaya, Malwadi, Hadpsar OPD No. 6, Department of Panchkarma, Sane Guruji Arogya Kendra, Hadpsar, Malwadi, Pune 411028
Maharashtra, India
Pune
MAHARASHTRA
411028
India |
| Phone |
7972999739 |
| Fax |
|
| Email |
gadheprerna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Maya Gokhale |
| Designation |
Head of department of Panchkarma |
| Affiliation |
Sumitibhai Shah Ayurvedic Mahavidyalaya |
| Address |
Sumatibhai shah Ayurveda Mahavidyalaya, Malwadi, Hadpsar OPD No. 6, Department of Panchkarma, Sane Guruji Arogya Kendra, Hadpsar, Malwadi, Pune 411028
Maharashtra, India
Pune
MAHARASHTRA
411028
India |
| Phone |
9422323285 |
| Fax |
|
| Email |
drmayagokhale@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Prerna Vishvasrao Gadhe |
| Designation |
M.D. Scholar Panchkarma |
| Affiliation |
Sumitibhai Shah Ayurvedic Mahavidyalaya |
| Address |
Sumatibhai shah Ayurveda Mahavidyalaya, Malwadi, Hadpsar OPD No. 6, Department of Panchkarma, Sane Guruji Arogya Kendra, Hadpsar, Malwadi, Pune 411028
Maharashtra, India
Pune
MAHARASHTRA
411028
India |
| Phone |
7972999739 |
| Fax |
|
| Email |
gadheprerna@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF PANCHKARMA,SANE GURUJI AROGYA KENDRA, MALWADI HADPSAR,PUNE 411028 |
|
|
Primary Sponsor
|
| Name |
SANE GURUJI AROGYA KENDRA |
| Address |
SANE GURUJI AROGYA KENDRA,MALWADI,HADPSAR,PUNE 411028 |
| 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 |
| DR PRERNA VISHVASRAO GADHE |
SANE GURUJI AROGYA KENDRA |
OPD No. 6, Department of Panchkarma, Sane Guruji Arogya Kendra, Hadpsar, Malwadi, Pune 411028
Maharashtra, India
Pune
MAHARASHTRA |
7972999739
gadheprerna@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethical Committee |
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: JANUVISLESHAHÂ (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | piNDasvedaH, पिणà¥à¤¡à¤¸à¥à¤µà¥‡à¤¦à¤ƒ | (Procedure Reference: bhavprakash, Procedure details: kukkutanda pinda swedana will be done on the affected knee of the patient for 15-20min daily for 7 days )
| | 2 | Intervention Arm | Procedure | - | mAtrAbastiH, मातà¥à¤°à¤¾à¤¬à¤¸à¥à¤¤à¤¿à¤ƒ | (Procedure Reference: charak samhita, Procedure details: matra basti with tila taila will be given to patient of janusadhigatvaat along with kuukutanda pinda sweda on affected knee joint.)
|
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
PATIENTS OF JANUSANDHIGATVATA
PATIENTS WITH NIRAM AVASTHA OF DOSHAS
BASTI ARHA
SNEHANA ARHA
SWEDANA ARHA |
|
| ExclusionCriteria |
| Details |
Patient suffering from any other systemic disorder which interfere with the intervention.
H/o severe injury, fracture, dislocation, trauma of knee joint, knee joint operated.
Pregnant women.
If Patient is vegetarian and not willing for egg treatment. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Access the add on effect of Kukkutanda Pinda Sweda along with Matra Basti of Tila taila in Janusandhigata Vata |
Treatment Will be Given For 7DAYS. Assessment Will Be Done ON 0TH, 3RD AND 7TH Day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Access Effect Of Kukkutanda Pinda Sweda in Janusandhigata Vata |
Treatment Will be Given for 7DAYS. Assessment Will be done ON 0TH, 3RD AND 7TH DAY. |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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
Modification(s)
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
16/11/2023 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
THIS IS A COMPARATIVE CLINICAL STUDY OF TWO MODALITIES KUKKUTANDA PINDA SWEDA AND MATRA BASTI OF TILA TAILA IN JANUSANDHIGATAVATA. THE PRIMARY OBJECTIVE IS TO STUDY THE ADD ON EFFECT OF KUKKUTANDA PIND SWEDA ALONG WITH MATRA BASTI OF TILA TAILA IN JANUSANDHIGATAVATA. ONE GROUP OF JANUSANDHIGATAVATA WILL BE TREATED WITH KUKKUTANDA PINDA SWEDA AND MATRA BASTI OF TILA TAILA FOR 7 DAYS AND SECOND GROUP WILL BE TREATED WITH MATRA BASTI OF TILA TAILA FOR 7 DAYS. OBSERVATION WILL BE DRAWN FROM THE OUTCOME OF TREATMENT. |