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CTRI/2018/12/016654 [Registered on: 13/12/2018] Trial Registered
CTRI Number
Prospectively
Last Modified On: 12/12/2018
Post Graduate
Yes
Thesis
Type of Trial Interventional
Medical Device
Type of Study
Ayurveda
Study Design Other
Public Title of
Role of agnikarma and diet in lower back pain
Study
A CLINICAL STUDY ON AGNIKARMA AND DIP(DISCIPLINED AND INTELLIGENT
Scientific Title of
PERSON)DIET IN THE MANAGEMENT OF KATIGATASANDHI VATA WITH SPECIAL
Study
REFERENCE TO LUMBAR SPONDYLOSIS.
Trial Acronym
Secondary ID Identifier
Secondary IDs if
Any NIL NIL
Name DR S K GUPTA
Designation H.O.D Dept. OF SHALYA TANTRA
All india institute of ayurveda,mathura road,gautampuri,sarita
Affiliation
vihar,new delhi-76
Details of Department of shalya Tantra 5th floor academic block,All india
Principal institute of ayurveda,sarita vihar, gautampuri, new delhi
Investigator or
overall Trial Address South
Coordinator DELHI
(multi-center 110076
study) India
Phone 8368403099
Fax
Email [email protected]
Name DR S K GUPTA
Designation H.O.D Dept. OF SHALYA TANTRA
All india institute of ayurveda,mathura road,gautampuri,sarita
Affiliation
vihar,new delhi-76
Department of shalya Tantra 5th floor academic block,All india
Details of Contact institute of ayurveda,sarita vihar, gautampuri, new delhi
Person
Scientific Query Address South West
DELHI
110076
India
Phone 8368403099
Fax
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Email [email protected]
Name DrMONIKA SODE
Designation PG Scholar 1st year
All india institute of ayurveda,mathura road,gautampuri,sarita
Affiliation
vihar,new delhi-76
Department of shalya Tantra 5th floor academic block,All india
institute of ayurveda,sarita vihar, gautampuri, new delhi
Details of Contact
Person Address South
Public Query DELHI
110076
India
Phone 9540596304
Fax
Email
[email protected] Source of
All India Institute of Ayurveda, New Delhi
Monetary or
Material Support
Name all india institute of ayurveda
All India Institute of Ayurveda, Matura Road,Gautam
Address
puri,Sarita Vihar
Primary Sponsor
Type of
Research institution and hospital
Sponsor
Details of Name Address
Secondary NIL NIL
Sponsor
Countries of
India
Recruitment
No of Sites = 1
Name of
Principal Name of Site Site Address Phone/Fax/Email
Investigator
Sites of Study OPD No 6,
All India Ground Floor, 9540596304
Dr Monika Sode Institute of Hospital Block,
Ayurveda South West [email protected]
DELHI
No of Ethics Committees= 1
Details of Ethics Name of Committee Approval Status
Committee IEC Approved
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Regulatory Status
Clearance Status Not Applicable
from DCGI
Health Condition Health Type Condition
/ Problems Patients (1) ICD-10 Condition: M478||Other spondylosis,
Studied
Type Name Details
Four sessions of Agnikarma with Bindu dahan
Comparator Agni
vishesha by pancha dhatushalaka at the interval of
Agent Karma
Intervention / 7 days.
Comparator Four sessions of Agnikarma with Bindu dahan
Agent Agni Karma
vishesha by pancha dhatushalaka at the interval of
Intervention with DIP
7 days. This will be associated with DIP DIET -
Diet
Daily for 1 month
Age
20.00 Year(s)
From
Age To 60.00 Year(s)
Inclusion Criteria
Gender Both
Patients irrespective to their sex, religion, education and socio-
Details
economic status with cardinal features of Lumbar Spondylosis.
Patients of DM, TB of spine, fracture of spine, HIV, HBsAG, VDRL,
osteopenia / osteoporosis or fracture of lumbar spine,
Details
ExclusionCriteria Spondylolisthesis, ankylosing spondylosis, rheumatoid arthritis,
Malignancy of lumbar vertebra
Method of
Generating
Computer generated randomization
Random
Sequence
Method of
An Open list of random numbers
Concealment
Blinding/Masking
Open Label
Outcome TimePoints
Primary Outcome
Relief in cardinal symptoms of lumbar spondylosis. One Month
Outcome TimePoints
Secondary
Outcome Improvement in quality of life by WHO QOL Scale. 18 months
Total Sample Size="90"
Sample Size from India="90"
Target Sample Final Enrollment numbers achieved (Total)= "Applicable only for
Size Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for
Completed/Terminated trials"
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Phase of Trial Phase 2/ Phase 3
Date of First
Enrollment 20/12/2018
(India)
Date of Study
Completion Applicable only for Completed/Terminated trials
(India)
Date of First
Enrollment Date Missing
(Global)
Date of Study
Completion Applicable only for Completed/Terminated trials
(Global)
Years="1"
Estimated
Months="6"
Duration of Trial
Days="0"
Recruitment
Status of Trial Not Applicable
(Global)
Recruitment
Status of Trial Not Yet Recruiting
(India)
Publication
THE thesis work will be publish in reputed journal
Details
Individual
Participant Data Will individual participant data (IPD) be shared publicly (including data
(IPD) Sharing dictionaries)?
Statement
Sandhigata Vata is a clinical condition develops when vitiated Vayuis localized at
Kati Pradesha.The symptoms likeShoola, Shopha, Stambha etc. are
developed.During the process of pathogenesis, Kapha Avrit VyanVayu obstruct
the circulation of Rasa RaktaDhatu and gradually structural changes are
developed in Kati Pardesha.Acharya Charak has described this disease first time
as‘Sandhigata Anila’ under the chapter of Vatavyadhi(ch.ch.28/36). It is
characterized by the features of Shoola (pain),Shotha (swelling) and Akunchana
Prasarane Vedana (pain on flexion and extension of the joint), Hantisandhin
(structural changes). Madhava has given one extra feature i.e. Aatopa
(crepitus). Based upon its feature,Sandhigata Vata can be equated withLumbar
Spondylosis. Lumbar Spondylosis is a degenerative condition which affects the
lower spine. In a patient with Lumbar Spondylosis, the spine is compromised by
a narrowing of the space between the vertebrae, causing a variety of health
Brief Summary
problems ranging from back pain to neurological issues. WHO estimates that
about 80% of individuals older than 40 years have lumbar spondylosis,
increasing from 3% of individuals aged 20-29 years. Internationally, lumbar
spondylosis can be developed in persons as young as 20 years. It increases with,
and perhaps is an inevitable concomitant of age.Inmodern medicine various
treatment options are available like conservative treatment, surgical methods
but all modalities have their own limitation and complications. In Ayurveda
Snehana, Upanaha, Agnikarma, Raktamokshana, Katibasti, Virechana, Bhesaja
Chikitsa etc. have been recommended for management of Vatikdisorders.
Among these Agnikarma is a well-known para-surgical procedure and has its
own therapeutic value for treatment of Sandhigata Vata(Lumbar spondylosis).
Acharya Sushruta has mentioned Agnikarmaprocedure as a best among all
otherprocedure(su.su 12/3)and in this study Pancha Dhatu Shalaka has been
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selected for Agnikarma. It is suitable for heat transfer and to produce Samyak
Dagdha Vrana (ideal therapeutic burn). प ेSसितगिदात ितमऔषधितषे वत: ।।
प े सितगिदात ितमऔषधितषेवत: ।। (लोतल राज) That means those people have no use
to givemedicine who did not follow proper diet. And for those who actually follow
proper diet there is no need of medicine for them. Ahara(food), Nidra (sleep)
and Brahmacharya (celibacy) are the Traya Upastambhas (Trayopastambhas)
explained in Ayurveda. Among the three pillars, Ahara or food is a major
supporting pillar which helps in sustenance of life and maintenance of health.
One cannot imagine living without food. Acharya Charaka Samhita gives a
beautiful concept about Ahara and tells that the Ahara not only forms this body
but also forms the diseases which occur in us. If the wholesome food (Hita
Ahara) is responsible for Sukha (happiness, health), the unwholesome food
(AhitaAhara) causes Dukha (misery, unhealthy). He also tells that Ahara or food
is the best among the things which sustain the life.(ch.su.28/45) Kashyapa tells
that no medicine is equivalent to the Aharaor food. He also calls Ahara as Maha
Bhaishajya (greatest and best medicine). Just by the administration of proper
food and diet it is possible to cure the diseases even without the need of
administration of medicines and treatment.(ka.sm.khl.4/5) Any disease can be
comprehensively cured without any medicine by just following ‘pathya Ahara’ or
wholesome food whereas even hundreds of medicines and formulations cannot
cure a disease in the absence of a planned wholesome regimen of diet.
Close
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