| CTRI Number |
CTRI/2021/05/033654 [Registered on: 17/05/2021] Trial Registered Prospectively |
| Last Modified On: |
15/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Role of Tila taila katibasti and pinda sweda of erand in management of Grudrasi i.e
Sciatica |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the efficacy of Tila Taila katibasti with erand Patra pinda sweda and tila Taila katibasti in ghridrasi |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ruchita Gurudas Pal |
| Designation |
M. D. SCHOLAR PANCHAKARMA |
| Affiliation |
SUMATIBHAI SHAH AYURVEDA MAHAVIDYALAYA, MALWADI, HADAPSAR, PUNE. |
| Address |
Department of Panchkarma, Sumatibhai Shah Ayurved Mahavidyalaya, Hadapsar, Pune
411028
OPD no 6 Sane Guruji Hospital, Malwadi, Hadapsar, Pune
411028
Pune
MAHARASHTRA
411028
India |
| Phone |
9834367303 |
| Fax |
|
| Email |
ruchitapal2022@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MAYA VIVEK GOKHALE |
| Designation |
HOD PANCHAKARMA DEPARTMENT |
| Affiliation |
SUMATIBHAI SHAH AYURVEDA MAHAVIDYALAYA, MALWADI, HADAPSAR, PUNE |
| Address |
SUMATIBHAI SHAH AYURVEDA MAHAVIDYALAYA ,MALWADI, HADPSAR, PUNE OPD NO. 6, DEPARTMENT OF PANCHAKARMA, SANE GURUJI AROGYA KENDRA, MALWADI, HADAPSAR, PUNE 411028
PUNE
MAHARASHTRA
411028
INDIA
Pune
MAHARASHTRA
411028
India |
| Phone |
9422323285 |
| Fax |
|
| Email |
drmayagokhale@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR RUCHITA GURUDAS PAL |
| Designation |
M. D. SCHOLAR PANCHAKARMA |
| Affiliation |
SUMATIBHAI SHAH AYURVEDA MAHAVIDYALAYA, MALWADI, HADAPSAR, PUNE. |
| Address |
SUMATIBHAI SHAH AYURVEDA MAHAVIDYALAYA ,MALWADI, HADPSAR, PUNE OPD NO. 6, DEPARTMENT OF PANCHAKARMA, SANE GURUJI AROGYA KENDRA, MALWADI, HADAPSAR, PUNE 411028
PUNE
MAHARASHTRA
411028
INDIA
Pune
MAHARASHTRA
411028
India |
| Phone |
9834367303 |
| Fax |
|
| Email |
ruchitapal2022@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Panchkarma Sumatibhai Shah Ayurved Mahavidyalaya Hadapsar Pune 411028 |
|
|
Primary Sponsor
|
| Name |
Sane Guruji Arogya Kendra |
| Address |
Sane Guruji Hospital Malwadi Hadapsar 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 Ruchita Gurudas Pal |
Sane Guruji Arogya Kendra |
OPD no 6,Sane Guruji Hospital, Malwadi, Hadapsar, Pune 411028
Pune
MAHARASHTRA |
9834367303
ruchitapal2022@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G55||Nerve root and plexus compressionsin diseases classified elsewhere. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Tila Taila Katibasti |
Tila taila is Ayurvedic Medicinal oil also known as sesame oil.Katibasti is local procedure win which the painful area is identified and with the help of plastic mold the luke warm sesame oil will pour into katibasti mold thus it will give local sudation to specific area. this treatment will be continued to 7 days. |
| Comparator Agent |
TILA TAILA KATIBASTI WITH ERANDA PATRA PINDA SWEDA. |
Tila taila is Ayurvedic Medicinal oil also known as sesame oil.Katibasti is local procedure win which the painful area is identified and with the help of plastic mold the luke warm sesame oil will pour into katibasti mold thus it will give local sudation to specific area. this treatment will be continued to 7 days. Tila taila katibati is give to patient of Gridhrasi i.e. Sciatica along with erand patra pinda sweda. Erada is also known as Castor. Erand Patra Pinda Sweda is a type of Sweda in which Castor leaves are fried in sesame oil and are used for sudation procedure. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with classical Sign and Symptoms of Gridhrasi.
Snehan Arha.
Swedan Arha.
|
|
| ExclusionCriteria |
| Details |
Fracture Conditions.
Any other systemic Conditions which may interfere the treatment – K/C/O- TB, CA.
Rheumatoid Arthritis.
Pregnant Women.
Trauma. |
|
|
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 compare the effect of combination of Tila Taila Katibasti and Erandapatra Pinda Sweda with only Tila Taila Katibasti once in a day for seven days in the management of Gridhrasi. |
TREATMENT WILL BE GIVEN FOR 7 DAYS. PATIENTS WILL BE ASSESSED ON 1, 3, 7 TH DAY. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the effect of Tila Tila Katibasti with Eranda Patra Pinda
Sweda in Gridhrasi. |
Treatment will be given for 7 days. Patients will be assessed on 1, 3, 7 TH day. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/06/2021 |
| 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="6"
Days="0" |
|
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)?
Response - NO
|
|
Brief Summary
|
This is a clinical study to evaluate the efficacy of TILA TAILA KTIBASTI WITH ERANDA PATRA PINDA SWEDA AND TILA TAILA KATIBASTI IN GRIDHRASI.The primary objective of sudy is to compare efficacy of TILA TAILA KATIBASTI WITH ERANDA PATRA PINDA SWEDA AND TILA TAILA KATIBASTI IN GRIDHRASI. TILA TAILA KATIBASTI will be given to both group of patients with GRIDHRASI. One group of GRIDHRASI patients will be treated with TILA TAILA KATIBASTI with ERANDA PATRA PINDA SWEDA for 7 days. Second group of GRIDHRASI patients will be treated with only TILA TAILA KATIBASTI for 7 days. Observation will be drawn from outcome of treatment. |