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CTRI Number  CTRI/2020/11/029386 [Registered on: 26/11/2020] Trial Registered Prospectively
Last Modified On: 25/11/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Jaloukavacharana(LEECH THERAPY) A Painless Procedure in VATAKANTAKA(Calcaneal Spur) 
Scientific Title of Study   “A Randomized Comparative Clinical Study to evaluate the Analgesic effect of Jaloukavacharana and Siravyadha in Vatakantaka with special reference to Calcaneal Spur” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kavyashree Kodekalmath 
Designation  PG Scholar 
Affiliation  BVVS Ayurved Medical College and Hospital Bagalkot 587101 KARNATAKA 
Address  I G KODEKALMATH HOUSE NO 233 VIVEK NAGAR EAST NEAR IBRAHIMPUR RAILWAY GATE VIJAYAPUR DIST VIJAYAPUR 586101 KARNATAKA
I G KODEKALMATH HOUSE NO 509 KODEKAL TQ HUNASHAGI DIST YADAGIRI KARNATAKA
Bijapur
KARNATAKA
586101
India 
Phone  8904900256  
Fax    
Email  kavyakodekalmath2@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR M M Salimath 
Designation  Principal and Professor Department of PG Studies in Shalyatantra 
Affiliation  BVVS AYURVED MEDICAL COLLEGE AND HOSPITAL BAGALKOT 587101 KARNATAKA 
Address  BVVS Ayurved Medical College and Hospital BVVS Campus Bagalkot 587101 KARNATAKA

Bagalkot
KARNATAKA
587101
India 
Phone  9845010950  
Fax    
Email  dr_mahantesh@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  DR M M Salimath 
Designation  Principal and Professor Department of PG Studies in Shalyatantra 
Affiliation  BVVS AYURVED MEDICAL COLLEGE AND HOSPITAL BAGALKOT 587101 KARNATAKA 
Address  BVVS Ayurved Medical College and Hospital BVVS Campus Bagalkot 587101 KARNATAKA

Bagalkot
KARNATAKA
587101
India 
Phone  9845010950  
Fax    
Email  dr_mahantesh@yahoo.com  
 
Source of Monetary or Material Support  
Self from Shalyatantra OPD BVVS Ayurved Medical College and Hospital Bagalkot 
 
Primary Sponsor  
Name  Self Dr Kavyashree Kodekalmath 
Address  BVVS Ayurved Medical College and Hospital Bagalkot 587101 KARNATAKA 
Type of Sponsor  Private medical college 
 
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 
Kavyashree Kodekalmath  Shalyatantra opd BVVS Ayurved Hospital Bagalkot  BVVS AMCH BVVS Campus Bagalkot
Bagalkot
KARNATAKA 
8904900256

kavyakodekalmath2@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC BVVS AYURVED MEDICAL COLLEGE AND HOSPITAL BAGALKOT  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
Comparator Agent  Standard Group :Siravyadha  siravyadana will be done by pricking needle at 2 angula above the kshipramarma. 
Intervention  Study Group :Jaloukavacharana  Prick the vein 2 angula above the Kshipramarma by needle and apply jalouka.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient presenting with pain in the heel region having Vatakantaka (Calcaneal Spur)
Patients of either sex aged between of 20-60years
Patients who are fit for Jaloukavacharana and Siravyadhana procedure 
 
ExclusionCriteria 
Details  Patients suffering from bleeding disorders and Anemia
Patients suffering with systemic diseases including DM, HTN and Cardiac diseases
Pregnancy and lactating women.
Patients with HIV/HbsAg/HCV positive are excluded. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Raktamokshana procedure acts as analgesic agent and also helps to reduce swelling   within average of 15 days 
 
Secondary Outcome  
Outcome  TimePoints 
Raktamokshana procedure acts as analgesic and reduces swelling   within average of 15 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   N/A 
Date of First Enrollment (India)   26/11/2020 
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="6"
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  

Vatakantaka is one among the Vataja Nanatmaja Vyadhi. The vitiated Vata in khudapradesha is the main cause for the disease, which is characterized by Kantakavat Shoola (severe pricking pain) in padatala pradesh. Nidana for Vatakantaka are improper placing the feet on the ground while walking (vishamampade) or exhaustion due to excess of walking (atishrama).1

                                                                                    Pain in the heel region can be subdivided according to the region affected as pain within the heel, pain behind the heel and pain beneath the heel.2 Calcaneal Spur is a bony projection forwards from undersurface of the calcaneal tuberosity3 and it is characterized by pain within and beneath the heel region hence, it can be correlated to Vatakantaka. The causes are mainly repeated attacks of plantar fasciitis, repeated trauma, ill fitting footwear, constant pulls of the shortened plantar fascia and fibromatosis of plantar fascia.4 Calcaneal Spur is characterized by pain over ball of the heel, tenderness on plantar aspect of the heel with slight swelling at the attachment of plantar fascia.5

                                                                                                                The study on incidence of calcaneal spur in Indian population with heel pain is around 59%, in which females, obese, middle age and young athletes group are mostly affected.6 Current conservative treatment modalities includes treating the causative factor, rest, non steroidal anti inflammatory drugs, local infiltration of hydrocortisone and microcellular rubber or placing a soft pad under the tender heel.7 These non steroidal anti inflammatory drugs  produce adverse effect like gastric irritation.

                                                                                    Surgery as a last resort is done either by chiseling off the bony spur with division of plantar fascia or endoscopic plantar fasciotomy. But some potential postoperative complications of surgery which include recurrent heel pain, permanent local numbness, painful nerve entrapment, wound dehiscence, infections and hypertrophic scar. It requires hospitalization and is expensive for the patient. And above all there is always a good chance of recurrence in these treatment modalities.

                                                                                    According to Acharya Chakradatta the treatment for Vatakantaka includes Raktavasechana, Erandatailapana, Agnikarma8 and Samanya vatavyadh ichikitsa.9 Jaloukavacharana and Siravyadha are one among various types of Raktavasechana.

                                                                                    Jaloukavacharana is one among the Ashashtrakrut Raktamokshanopaya, it is indicated in Avagadha Avastha and Grathita Avastha10 of Doshas and can also be used in all the conditions where Raktavasechana is indicated (Sarvani Sarverva).11 Hence, Considering above factors to manage pain in Vatakantaka, Jaloukavacharana is taken for study group.

                                                                                    Acharya Sushruta specified the use of Siravyadha in Vatakantaka12 and by previous research studies on Siravyadha is taken as standard procedure for present study. As Jaloukavacharana is safest procedure, cost effective and it is carried out in Bala, Vrudha, Biru, Sukumara and Durbala. Hence the present study is undertaken to compare the analgesic effect on Jaloukavacharana and Siravyadha in Vatakantaka with special reference to Calcaneal  Spur.


 
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