CTRI Number |
CTRI/2021/03/031624 [Registered on: 01/03/2021] Trial Registered Prospectively |
Last Modified On: |
25/02/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Ayurvedic treatment for pain, swelling and tenderness. |
Scientific Title of Study
|
“A comparative clinical trial on the effect of vachadi upanaha and kolakulatthadi upanaha in the pain management of vatakantaka (plantar fascitis)†|
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Rachita Desmukh |
Designation |
PG Scholar |
Affiliation |
Gavisiddeshwara Ayurvedic Madical College, Post Graduate Studies and Research Center. Koppal |
Address |
Shree Jagadguru Gavisiddeshwara Ayurvedic Madical College, Post Graduate Studies and Research Center. Koppal 583231 Karnataka
Koppal
KARNATAKA
583231
India
Koppal KARNATAKA 583231 India |
Phone |
8971997505 |
Fax |
|
Email |
rachitadeshmukh132@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Manjunath Akki |
Designation |
professor |
Affiliation |
Gavisiddeshwara Ayurvedic Madical College, Post Graduate Studies and Research Center. Koppal |
Address |
DEPT Of Panchakarma Gavisiddeshwara Ayurvedic Madical College, Post Graduate Studies and Research Center. Koppal 583231 Karnataka
Koppal
KARNATAKA
583231
India
Koppal KARNATAKA 583231 India |
Phone |
8123044125 |
Fax |
|
Email |
drmanju78@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Manjunath Akki |
Designation |
professor |
Affiliation |
Gavisiddeshwara Ayurvedic Madical College, Post Graduate Studies and Research Center. Koppal |
Address |
DEPT Of Panchakarma Gavisiddeshwara Ayurvedic Madical College, Post Graduate Studies and Research Center. Koppal 583231 Karnataka
Koppal
KARNATAKA
583231
India
Koppal KARNATAKA 583231 India |
Phone |
8123044125 |
Fax |
|
Email |
drmanju78@gmail.com |
|
Source of Monetary or Material Support
|
shree jagadguru gavisiddeshwara ayurvedic medical college and research center gavimutt koppal |
|
Primary Sponsor
|
Name |
Shree Jagadguru gavisidheswara ayurvedic medical college postgraduate studies and research centre |
Address |
Room 05 DEPT Of Panchakarma Gavisiddeshwara Ayurvedic Madical College, Post Graduate Studies and Research Center. Koppal 583231 Karnataka Koppal KARNATAKA 583231 India |
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 Rachita Desmukh |
SJGAMC KOPPAL |
Room 5 ,department of panchakarma ,Shree Jagadguru gavisidheswara ayurvedic medical college postgraduate studies and research centre Koppal Koppal KARNATAKA |
8971997505
rachitadeshmukh132@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTIONAL CLINICAL ETHICAL COMMITTEE |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:M858||Other specified disorders of bonedensity and structure. Ayurveda Condition: VATAKANTAKAM, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Kolakulatthadi Upanaha |
LOCAL EXTERNAL APPLICATION 12 HOURS PER DAY FOR 7 DAYS |
Intervention |
Vachadi Upanaha |
LOCAL EXTERNAL APPLICATION 12 HOURS PER DAY FOR 7 DAYS |
|
Inclusion Criteria
|
Age From |
25.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
•The patients, who are presenting with the classical features of Vatakantaka
•Patients fit for Swedana.
•Patients between 25 to 60 years, Irrespective of sex.
|
|
ExclusionCriteria |
Details |
•Patients suffering fromTrauma, fractures and dislocation of Ankle joint
•Rheumatoid Arthritis, Gouty Arthritis and any other Orthopedic Disorder causing pain in the Sole of the Foot.
•Patient suffering from other systemic disorders.
•Sensitive skin.
|
|
Method of Generating Random Sequence
|
Random Number Table |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Reduced Heel Pain (assessment by V.A.S),Swelling,tenserness
|
07days |
|
Secondary Outcome
|
Outcome |
TimePoints |
Reduced Heel Pain (assessment by V.A.S),Swelling,tenserness
|
14 days |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
01/03/2021 |
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="0" Months="3" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
A painful condition of heel and
aggravated Vata due to exertion over Gulfasandhi is known to be Vatakantaka. Pain in heel is produced due to walking on uneven and lopsided surface and due
to which Vata takes ashraya in Gulfa sandhi.
Inflammation of the plantar fascia leads
to pain with or without swelling and stiffness on the plantar aspect of heel.
The pain is typically most severe after getting up from bed in the morning when
the patient is unable to walk few steps initially.
With these clinical presentation,
the disorder Vatakantaka can be co-related with Plantar fascitis.
Incidence of Plantar
fascitis in Indian population with heel pain is 59%, among them women are more
prone. Most common age group affected is 30-60 years.
Acharya’s mentioned that the disease’s located
in Snayu, Asthi and Sandhi should be treated with, Agnikarma, Sneha Upanaha, Bandhana
and Mardana.
Acharya Susruta has
mentioned Upanaha is vata shamaka. Upanaha sweda is done by
application of warm paste of drugs macerated with sour liquid and added Sneha,
then tied on the affected body parts. An attempt of Vachadi Upanaha
and Kolakulatthadi Upanaha is made to manage the pain in and around ankle joint
which hampers day to day activities of the patients.
Thus the present study
is selected for comparative study of Vachadi Upanaha and Kolakulatthadi
Upanaha in Vatakantaka. |