FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2018/12/016654 [Registered on: 13/12/2018] Trial Registered Prospectively
Last Modified On: 12/12/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Ayurveda 
Study Design  Other 
Public Title of Study   Role of agnikarma and diet in lower back pain 
Scientific Title of Study   A CLINICAL STUDY ON AGNIKARMA AND DIP(DISCIPLINED AND INTELLIGENT PERSON)DIET IN THE MANAGEMENT OF KATIGATASANDHI VATA WITH SPECIAL REFERENCE TO LUMBAR SPONDYLOSIS. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR S K GUPTA 
Designation  H.O.D Dept. OF SHALYA TANTRA 
Affiliation  All india institute of ayurveda,mathura road,gautampuri,sarita vihar,new delhi-76 
Address  Department of shalya Tantra 5th floor academic block,All india institute of ayurveda,sarita vihar, gautampuri, new delhi

South
DELHI
110076
India 
Phone  8368403099  
Fax    
Email  drskgupta17@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR S K GUPTA 
Designation  H.O.D Dept. OF SHALYA TANTRA 
Affiliation  All india institute of ayurveda,mathura road,gautampuri,sarita vihar,new delhi-76 
Address  Department of shalya Tantra 5th floor academic block,All india institute of ayurveda,sarita vihar, gautampuri, new delhi

South West
DELHI
110076
India 
Phone  8368403099  
Fax    
Email  drskgupta17@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrMONIKA SODE 
Designation  PG Scholar 1st year 
Affiliation  All india institute of ayurveda,mathura road,gautampuri,sarita vihar,new delhi-76 
Address  Department of shalya Tantra 5th floor academic block,All india institute of ayurveda,sarita vihar, gautampuri, new delhi

South
DELHI
110076
India 
Phone  9540596304  
Fax    
Email  monikasode0@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Ayurveda, New Delhi 
 
Primary Sponsor  
Name  all india institute of ayurveda 
Address  All India Institute of Ayurveda, Matura Road,Gautam puri,Sarita Vihar 
Type of Sponsor  Research institution and hospital 
 
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 
Dr Monika Sode  All India Institute of Ayurveda  OPD No 6, Ground Floor, Hospital Block,
South West
DELHI 		 9540596304

monikasode0@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M478||Other spondylosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Agni Karma  Four sessions of Agnikarma with Bindu dahan vishesha by pancha dhatushalaka at the interval of 7 days. 
Intervention  Agni Karma with DIP Diet  Four sessions of Agnikarma with Bindu dahan vishesha by pancha dhatushalaka at the interval of 7 days. This will be associated with DIP DIET - Daily for 1 month 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients irrespective to their sex, religion, education and socio-economic status with cardinal features of Lumbar Spondylosis. 
 
ExclusionCriteria 
Details  Patients of DM, TB of spine, fracture of spine, HIV, HBsAG, VDRL, osteopenia / osteoporosis or fracture of lumbar spine, Spondylolisthesis, ankylosing spondylosis, rheumatoid arthritis, Malignancy of lumbar vertebra 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Relief in cardinal symptoms of lumbar spondylosis.  One Month 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in quality of life by WHO QOL Scale.  18 months 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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/ Phase 3 
Date of First Enrollment (India)   20/12/2018 
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   THE thesis work will be publish in reputed journal 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   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 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 selected for Agnikarma. It is suitable for heat transfer and to produce Samyak Dagdha Vrana (ideal therapeutic burn). पथ्येSसतिगदाितस्यतिमऔषधतिषेवर्त: ।। पथ्येसतिगदाितस्यतिमऔषधतिषेवर्त: ।। (लोतलम्बराज) 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