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
|
|
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
|
|
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. |