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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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