| CTRI Number |
CTRI/2020/02/023105 [Registered on: 04/02/2020] Trial Registered Prospectively |
| Last Modified On: |
01/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to evaluate the effectiveness of application of medicated oil bandaging on foot in patients of Heel Pain. |
|
Scientific Title of Study
|
AN OPEN LABEL CLINICAL STUDY TO EVALUATE THE EFFECTIVENESS OF PADAPICHU BANDHANA WITH NIRGUNDI TAILA IN VATAKANTAKA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chilly Priyadarsini Sahoo |
| Designation |
Post Graduate Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Departmentof Panchakarma
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan 573201 Karnataka
India
Hassan
KARNATAKA
573201
India |
| Phone |
9178259905 |
| Fax |
|
| Email |
sahoochilly@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chilly Priyadarsini Sahoo |
| Designation |
Post Graduate Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Departmentof Panchakarma
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan 573201 Karnataka
India
Hassan
KARNATAKA
573201
India |
| Phone |
9178259905 |
| Fax |
|
| Email |
sahoochilly@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashvini Kumar M |
| Designation |
Professor and Head Of Department |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Department of Panchakarma
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan 573201 Karnataka
India
Hassan
KARNATAKA
573201
India |
| Phone |
9448705660 |
| Fax |
|
| Email |
ashvinipanchakarma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan 573201 Karnataka
India |
|
|
Primary Sponsor
|
| Name |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
BM Road Thanniruhalla Hassan 573201 Karnataka
India |
| Type of Sponsor |
Private medical college |
|
|
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 Chilly Priyadarsini Sahoo |
OPD 2 Department of Panchakarma |
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan 573201 Karnataka
India
Hassan
KARNATAKA |
09178259905
sahoochilly@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M678||Other specified disorders of synovium and tendon, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Padapichu Bandhana with Nirgundi Taila |
Padapichu Bandhana with Nirgundi Taila for 8 hours once in a day for 14 consecutive days. |
| Comparator Agent |
Padapichu Bandhana with Nirgundi Taila and Trayodashanga Guggulu |
Padapichu Bandhana with Nirgundi Taila for 8 hours once in a day for 14 consecutive days and Trayodashanga Guggulu(2gm three times a day) for consecutive 14 days. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects fulfilling the diagnostic criteria.
2.Subjects with symptoms of Plantar Fascitis, Calcaneal spur.
3.Subjects with either gender between age group 20-60years.
4.Subjects who are willing to participate and sign the informed consent form. |
|
| ExclusionCriteria |
| Details |
1.Subjects with fracture and dislocation of ankle joint, foot and sprain.
2.Subjects with impaired circulation to lower extremities.
3.Subjects with systemic disorders.
4.Subjects with foot infection. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Signs and symptoms of vatakantaka will be assessed as like pain , stiffness , tenderness , swelling , redness , loss of function, walking time,foot pressure and the assessement will be done on day first-before treatment , Day 7th –Mid Treatment, Day 14th-After Treatment, and Day 28th -for Follow Up. |
Signs and symptoms of vatakantaka will be assessed as like pain , stiffness , tenderness , swelling , redness , loss of function, walking time,foot pressure and the assessement will be done on day first-before treatment , Day 7th –Mid Treatment, Day 14th-After Treatment, and Day 28th -for Follow Up. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
07/02/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is an open
label, double arm, prospective, comparative clinical study to know the
effectiveness of
A. PadapichuBandhana with
NirgundiTaila for 8 hours once in a day for 14 consecutive days for 20
patients.
B. PadapichuBandhana with
NirgundiTaila for 8 hours once in a day for 14 consecutive days and
trayodashangaguggulu (2gm three times a day) for 14 days for 20
patients.
That will be conducted in India. |