| CTRI Number |
CTRI/2019/11/022132 [Registered on: 25/11/2019] Trial Registered Prospectively |
| Last Modified On: |
01/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Clinical trial in the management of Vatakantaka with special reference to calcaneal spur with valuka swedana and dashamulachurna pindaswedana in two parallel groups A and B followed by internal medicine nirgundi guggulu |
|
Scientific Title of Study
|
A Comparative Clinical Study To Evaluate The Effect Of Shamana Sweda Followed By Nirgundi Guggulu In Vaatakantaka With Special Reference To Calcaneal Spur Amongst Female Population |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S G Chavan |
| Designation |
Professor Department Of Kayachikitsa |
| Affiliation |
Ayurveda Mahavidyalaya And Hospital |
| Address |
Ayurveda Mahavidyalaya And Hospital
Department of Kayachikitsa
Divission A
Room no 15
Heggeri Extension
Hubballi
Pincode 580024
Phone 0836 2208693
Mail amvhhubli54@gmail.com
Ayurveda Mahavidyalaya And Hospital
Department of Kayachikitsa
Divission A
Room no 15
Heggeri Extension
Hubballi
Pincode 580024
Phone 0836 2208693
Mail amvhhubli54@gmail.com
Dharwad
KARNATAKA
580024
India |
| Phone |
9448335479 |
| Fax |
|
| Email |
shivajichavan1671@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suma Astagimath |
| Designation |
PG Scholor |
| Affiliation |
Ayurveda Mahavidyalaya And Hospital |
| Address |
Ayurveda Mahavidyalaya And Hospital
Department of Kayachikitsa
Divission A
Room no 15
Heggeri Extension
Hubballi
Pincode 580024
Phone 0836 2208693
Mail amvhhubli54@gmail.com
Ayurveda Mahavidyalaya And Hospital
Department of Kayachikitsa
Divission A
Room no 15
Heggeri Extension
Hubballi
Pincode 580024
Phone 0836 2208693
Mail amvhhubli54@gmail.com
Dharwad
KARNATAKA
580024
India |
| Phone |
9148071075 |
| Fax |
|
| Email |
sumaastagimath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S G Chavan |
| Designation |
Professor Department Of Kayachikitsa |
| Affiliation |
Ayurveda Mahavidyalaya And Hospital |
| Address |
Ayurveda Mahavidyalaya And Hospital
Department of Kayachikitsa
Divission A
Room no 11
Heggeri Extension
Hubballi
Pincode 580024
Phone 0836 2208693
Mail amvhhubli54@gmail.com
Ayurveda Mahavidyalaya And Hospital
Department of Kayachikitsa
Divission A
Room no 11
Heggeri Extension
Hubballi
Pincode 580024
Phone 0836 2208693
Mail amvhhubli54@gmail.com
Dharwad
KARNATAKA
580024
India |
| Phone |
9448335479 |
| Fax |
|
| Email |
shivajichavan1671@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurveda Mahavidyalaya And Hospital
Heggeri Extension
Hubballi
Pincode 580024
Phone 0836 2208693
Mail amvhhubli54@gmail.com |
|
|
Primary Sponsor
|
| Name |
Ayurveda Mahavidyalaya And Hospital |
| Address |
Ayurveda Mahavidyalaya And Hospital
Heggeri Extension
Hubballi
Pincode 580024
Phone 0836 2208693
Mail amvhhubli54@gmail.com |
| 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 S G Chavan |
Ayurveda Mahavidyalaya And Hospital |
Department of Kayachikitsa
Divission A
Room no 11
Heggeri Extension
Hubballi
Pincode 580024
Phone 0836 2208693
Mail amvhhubli54@gmail.com
Dharwad
KARNATAKA |
9448335479
shivajichavan1671@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: M859||Disorder of bone density and structure, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dashamula Churnapinda Sweda And Nirgundi Guggulu. |
250GMS Fine Powder Of Dashamula Churna Is Heated And Made Into Pottali To Do Swedana Externally On Heel For 7 days.
Nirgundi Guggulu 500MG 2 Tablets Twice a Day Orally For 30 Days. |
| Comparator Agent |
Valuka Sweda And Nirgundi Guggulu. |
250GMS Of Valuka Is Heated And Made Into Pottali To Do Swedana Externally On Heel For 7 Days.
Nirgundi Guggulu 500MG 2 Tablets Twice A Day Orally For 30 Days. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Patients with the Lakshanas of Vaatakantaka like pain in heel, pain on walking etc
Female patients between the age group of 30-65 years.
Patients who are fit for swedana karma.
|
|
| ExclusionCriteria |
| Details |
Patients suffering from fracture, Dislocation of ankle joint, Post traumatic ankylosis, Rheumatoid arthritis, Gouty arthritis and any orthopedic disorders causing pain in the sole of foot.
Pregnant and lactating women
Subjects with uncontrolled Diabetes with complications.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Morning rise of pain
Pain on walking
Pain on walking after rest
Pain on walking on uneven surface
|
On 55th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Tenderness
Heel test
|
At 55th Day
|
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
15/12/2019 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
40 subjects of vatakantaka (calcaneal spur) will be selected randomly and divided into 2 equal groups Group A and Group B. To Compare The Combined Effect Of Dashamula Churnapinda Sweda And Nirgundi Guggulu, With Valuka Sweda And Nirgundi Guggulu. |