| CTRI Number |
CTRI/2019/03/018330 [Registered on: 29/03/2019] Trial Registered Prospectively |
| Last Modified On: |
21/03/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
RCT on Churna Pinda Sweda(Bolus of herbal powder) and SWD(Shortwave Diathermy)in Katigraha (Low backache) |
|
Scientific Title of Study
|
A comparative clinical study of Churna Pinda Sweda and SWD(Shortwave Diathermy) in the management of Katigraha. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Armeda Malang |
| Designation |
PG Scholar, Parul Institute of Ayurved |
| Affiliation |
Parul Institute of Ayurveda |
| Address |
Panchakarma Dept. Parul Institute of Ayurved, Parul University P.O. Limda, Waghodia, dist Vadodara Gujarat-391760
Vadodara
GUJARAT
391760
India |
| Phone |
8415808877 |
| Fax |
|
| Email |
dr.medamalang@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr KBRoy |
| Designation |
Professor of Parul Institute of Ayurved |
| Affiliation |
Parul Institute of Ayurveda |
| Address |
Panchakarma Dept. Parul Institute of Ayurved, Parul University P.O Limda, Waghodia, dist Vadodara Gujarat-391760
Vadodara
GUJARAT
391760
India |
| Phone |
9825912141 |
| Fax |
|
| Email |
dr_kbroy@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Armeda Malang |
| Designation |
PG Scholar, Parul Institute of Ayurveda |
| Affiliation |
Parul Institute of Ayurveda |
| Address |
Panchakarma Dept. Parul Institute of Ayurved, Parul University P.O Limda, Waghodia, dist Vadodara Gujarat-391760
Vadodara
GUJARAT
391760
India |
| Phone |
8415807788 |
| Fax |
|
| Email |
dr.medamalang@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Ayurveda Hospital
Parul University P.O.Limda,Tal Waghodia-391760 Dist.Vadodara, Gujarat. |
|
|
Primary Sponsor
|
| Name |
Armeda Malang |
| Address |
Panchakarma Dept. Parul Institute of Ayurved, Parul University P.O Limda, Waghodia, dist Vadodara Gujarat-391760 |
| 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 |
| Dr Armeda Malang |
Parul Institute of Aurved and Hospital |
Panchakarma Department
Parul Institute of Ayurved and Hospital
Parul University.P.O.Limda Tal Waghodia-391760 Dist. Vadodara, Gujarat.
Vadodara
GUJARAT |
8415808877
dr.medamalang@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee for Human Research (IECHR) Parul Institute of Ayurved Parul University limda tal Waghodia Vadodara ,391760, Gujarat, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M545||Low back pain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Churna Pinda Sweda |
Materials required:Kolakulathadi Churna, Dhanyamla.cloth,vessels.
Dosage in form of external application 150 grams of Kolakulathadi Churna in bolus cooked and dipped into 500 ml of Dhanyamla for 20 mins daily for 7 days.
|
| Comparator Agent |
Shortwave Diathermy |
Shortwave Diathermy machine, pillow,gel.It is administered 10 minutes regularly once a day for 7 days. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are fit for Swedana Karma and SWD( Shortwave Diathermy).
Diagnosed case of Katigraha |
|
| ExclusionCriteria |
| Details |
Patients suffering from any metabolic and systemic disorders.
Patients with the history of trauma.
Post surgical backache
Pregnancy
Conditions like Spondylolisthesis, Spina bifida, TB of Spine, Ankylosing spondylitis, Spinal Canal stenosis and Malignancies. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief sign and symptoms of Kati pradesha. |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement of the sign and symptoms with exercise |
1 month |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
02/04/2019 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not published yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In Katigraha the pain and restricted
movement are present in Katipradesha,
i.e. in between Uraha and Nitamba (lumbo sacral region). In other hand low back
pain is a chronic condition characterised by persistent dull or sharp pain on
the lower back. It may be associated with burning, stiffness, numbness or tingling
with the pain. The most common symptoms of non-specific low back pain are pain
and disability.
Low back pain is
a very common health problem worldwide and a major cause of disability. It
affects people of all ages, and is a very frequent reason for medical
consultations. Low back pain, a chronic and most common pain disorder which is
characterised by dull or sharp pain in the lower back it may also be associated
with burning or stiffness. The 2010 Global Burden of Disease Study estimated
that low back pain is one among the top 10 diseases. The lifetime prevalence of
non-specific low back pain is estimated at 60% to 70% in industrialized
countries. Prevalence increases and peaks between the ages of 35- 55.
Swedana karma is the next important and
essential Purvakarma after Snehana. It is also important pradhana
karma for the treatment of many diseases. Acharya
Charaka has included Swedana karma
under Shad Upakrama. Swedana relieves
stiffness, heaviness and coldness of the body and it induces sweat in the body.
Swedana is mainly of two types: Rooksha and Snigdha sweda. Rooksha sweda
are generally opted for the treatment of disorder caused by Vatakapha Dosha.
Churna Pinda Sweda is a form of Rooksha sweda which is included under
the category of Pinda Sweda. In this
procedure we use heated/oil fried herbal powders which have the property of
healing, pain, swelling, inflammation and degeneration tied in a bolus to
provide heat to the pain afflicted joints /body parts.
Physiotherapy is the treatment of
diseases, injury, or deformity by physical methods as massage, heat treatment
and exercise rather than by drugs or surgery. It also plays a role in
musculoskeletal disorders and shortwave
diathermy is one of the physiotherapy tools. |