CTRI Number |
CTRI/2017/08/009420 [Registered on: 21/08/2017] Trial Registered Retrospectively |
Last Modified On: |
11/08/2017 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda Other (Specify) [nil] |
Study Design |
Single Arm Study |
Public Title of Study
|
Effect of arka patra sweda in katigrha |
Scientific Title of Study
|
Clinical study to evaluate the efficacy of Arka patra sweda in the management of Kati Graha |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
Nil |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr mayur nagar |
Designation |
second year pg scholar |
Affiliation |
sri dharmasthala manjunatheshwara college of ayurveda and hospital hassan |
Address |
Department of Panchakarma Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM road Thannirulla Hassan Karnataka
Hassan KARNATAKA 573201 India |
Phone |
8095997047 |
Fax |
08172-256464 |
Email |
drmayur23vaidya@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Ashvini KumarM |
Designation |
Professor |
Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
Address |
Department of Panchakarma Sri dharmasthala manjunatheshwara college of ayurveda and hospital BM road Thannirulla Hassan Karnataka Hassan KARNATAKA 573201 India |
Phone |
9448705660 |
Fax |
08172-256464 |
Email |
ashvinipanchakarma@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Ashvini KumarM |
Designation |
Professor |
Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
Address |
Dr. Ashvini Kumar.M Professor Department of Panchakarma Sri dharmasthala manjunatheshwara college of ayurveda and hospital BM road thannirulla hassan karnataka Hassan KARNATAKA 573201 India |
Phone |
9448705660 |
Fax |
08172-256464 |
Email |
ashvinipanchakarma@gmail.com |
|
Source of Monetary or Material Support
|
Sri Dharmasthala Manjunatheswhwara College Of Ayurveda And Hospital, B M ROAD, TAMMIRUHALLA HASSAN |
|
Primary Sponsor
|
Name |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
Address |
Sri dharmasthala manjunatheshwara college of ayurveda and hospital BM road thannirulla hassan karnataka |
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 Mayur Nagar |
Sri dharmasthala manjunatheshwara college of ayurveda and hospital |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital,
Opd No 14, Department Of Panchakarma, Bm Road Thannirulla Hassan Karnataka
Hassan KARNATAKA |
8095997047 08172-256464 drmayur23vaidya@gmal.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee, Sri Dharmasthala Manjunatheshwra college of ayurveda and Hospital Hassan |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
katigraha, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Arka patra sweda continuosly for three consecutive days |
15-18 no of fresh medium size arka patras are well cleaned and are kept side by side without leaving gap on kora cloth of 25" length, 5" breath and then cloth and leaves are rolled together and tied from base with tag of 16" length and arka patra sweda is given for three consecutive days. after completion of treatment patient will be asked to take hot water bath. |
Comparator Agent |
nil |
nil |
Comparator Agent |
nil |
nil |
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
the patients who are fit for swedana
in between age group of 20-70 years of either sex will be selected |
|
ExclusionCriteria |
Details |
patients who are having low back ache due to any infection, organomegaly, viscerogenic.
patients with history of trauma.
post surgical backache |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
progress will be noted on basis of assesment parameters before and after traetment.
subjective criteria samyak swedana lakshanas
objective parametes - pain , stiffness , restricted movements of spine such as- flexion, extension, left lateral movement, right lateral movement, rotating movement
walking time |
3 DAYS |
|
Secondary Outcome
|
Outcome |
TimePoints |
none |
none |
|
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)
|
01/04/2017 |
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="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
will be done in due course of study |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Svedana is one of the
Shadvidha Upakram and is indicated in the management of various
Vatavyadhi’s and as well as for Vata-Kaphaja disorders .Svedana Karma can
be performed by various methods. Arkapatra Svedana is one among the modalities
of Svedana and practiced by traditional Ayurveda doctors
In Katigraha the Vedana, Stambha and
Cheshtastambha are present in Kati Pradesha may be caused by Kevala Vata or
Saama Vata. The symptoms of Saama Vata is Vedana, Toda, Stambha.
Svedana Karma plays a major role in
alleviating the pain and stiffness of joints. Svedana relieves stiffness,
heaviness and coldness of the body and it induce the body sweat. Svedana is of
three types viz. Rooksha, Snigdha and Snigdha Ruksha Sveda Rooksha Svedas are
generally opted in the treatment of disorders caused by Vata and kapha Doshas.
In Katigraha the Shoola
and restricted movements are present in whole of Kati Pradesha, i.e. in between
Uraha and Nitamba (lumbo sacral region). In other hand Low back pain is a
chronic condition characterized by a persistent dull or sharp pain per the
lower back. It may be also associated with burning, stiffness, numbness or
tingling with the pain. The most important symptoms of non-specific low back
pain are pain and disability.
Arka(Calatripis procera)
patra latex possess Tikta Rasa majorly and
little amount of Lavana Rasa, Singhdha and Laghu guna, Ushna VeeryaÂÂÂÂ
and leaves are Laghu Ruksha and Tikshna in Guna and having Vatahara, Vishaghana,
Rechana and Dipana properties. Saindhava
is aleviator of all three dosas and does not cause burning sensation. Ghee
alleviates Vata, Pitta, toxic conditions ,cold in potency and best of all the
unctuous substances. By virtue of all
above properties of Arka Patra , Arka Ksheera ,Saindhava and Ghee Arka Patra sveda may
reduce the pain in affected area.
In
this study 15 to 18 number of fresh Arka Patras are well cleaned and are kept
side by side without leaving gap on Kora cloth of 25 inches length x 5 inches
breadth and then cloth and leaves are rolled together and tied from the base
with tag of 16 inches length. In
the morning, Patients will be given 6 grams of Shunthi choorna along with luke
warm water in empty stomach Prepared Arka Patra bundle is cut from the base and
is heated on a hot pan with ghee and
Saindhava Lavana . Hot leaves are then
tapped on Kati Pradesha. Once the temperature of the leaves is lost, again they are cut, heated and tapped. This procedure is to be repeated till the
Samyak Svedana Lakshanas are seen or
upto 20 minutes. After completion of treatment, patient will be asked to take hot
water bath.
The numerical data will be assessed with
Student paired t-test. Ordinal data will be assessed with Friedmen’s test
followed by Post Hoc Analysis with Wilcoxon signed rank test with Bonferroni
correction applied. Changes observed (p<0.05) will be considered as
significant.
|