PDF of Trial CTRI Website URL - http://ctri.nic.in
Clinical Trial Details (PDF Generation Date :- Wed, 29 Sep 2021 04:42:50 GMT)
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 A Comparative Clinical Study To Evaluate The Effect Of Shamana Sweda Followed By Nirgundi Study Guggulu In Vaatakantaka With Special Reference To Calcaneal Spur Amongst Female Population Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Dr S G Chavan Trial Coordinator (multi-center study) 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 [email protected] Ayurveda Mahavidyalaya And Hospital Department of Kayachikitsa Divission A Room no 15 Heggeri Extension Hubballi Pincode 580024 Phone 0836 2208693 Mail [email protected] Dharwad KARNATAKA 580024 India Phone 9448335479 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Suma Astagimath Query) 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 [email protected] Ayurveda Mahavidyalaya And Hospital Department of Kayachikitsa Divission A Room no 15 Heggeri Extension Hubballi Pincode 580024 Phone 0836 2208693 Mail [email protected] Dharwad KARNATAKA 580024 India Phone 9148071075 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr S G Chavan
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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 [email protected] Ayurveda Mahavidyalaya And Hospital Department of Kayachikitsa Divission A Room no 11 Heggeri Extension Hubballi Pincode 580024 Phone 0836 2208693 Mail [email protected] Dharwad KARNATAKA 580024 India Phone 9448335479 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Ayurveda Mahavidyalaya And Hospital Heggeri Extension Hubballi Pincode 580024 Phone 0836 2208693 Mail [email protected] Primary Sponsor Primary Sponsor Details Name Ayurveda Mahavidyalaya And Hospital Address Ayurveda Mahavidyalaya And Hospital Heggeri Extension Hubballi Pincode 580024 Phone 0836 2208693 Mail [email protected] Type of Sponsor Other [Self] Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator DR S G Chavan Ayurveda Department of 9448335479 Mahavidyalaya And Kayachikitsa Divission Hospital A Room no 11 Heggeri shivajichavan1671@gm Extension Hubballi ail.com Pincode 580024 Phone 0836 2208693 Mail amv [email protected] Dharwad KARNATAKA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? INSTITUTIONAL Approved 20/03/2019 No ETHICAL COMMITTEE Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Disorder of bone density and structure, unspecified Intervention / Type Name Details Comparator Agent Intervention Dashamula Churnapinda 250GMS Fine Powder Of Sweda And Nirgundi Guggulu. Dashamula Churna Is Heated
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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 250GMS Of Valuka Is Heated Guggulu. 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 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.
Exclusion Criteria Exclusion Criteria 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 Coin toss, Lottery, toss of dice, shuffling cards etc Random Sequence Method of Not Applicable Concealment Blinding/Masking Open Label Primary Outcome Outcome Timepoints Morning rise of pain On 55th Day Pain on walking Pain on walking after rest Pain on walking on uneven surface
Secondary Outcome Outcome Timepoints Tenderness At 55th Day Heel test
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 15/12/2019 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=2 Trial Months=0 Days=0 Recruitment Status of Not Applicable Trial (Global)
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Recruitment Status of Open to Recruitment Trial (India) Publication Details Nil 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.
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