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CTRI Number  CTRI/2024/11/076629 [Registered on: 11/11/2024] Trial Registered Prospectively
Last Modified On: 09/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A Study Agnikarma With Tapta Guda Paka Locally And Sahacharadi Kashaya Orally in The Management of Prishtashoola (Lumbar Spondylosis)  
Scientific Title of Study   A clinical Study To Evaluate of Agnikarma With Tapta Guda Paka Locally And Sahacharadi Kashaya Orally in The Management of Prishtashoola (Lumbar Pain) W.S.R. to Lumbar Spondylosis. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nikhil Shankar Pandule 
Designation  PG scholar M.S.Shalyatantra 
Affiliation  Dayabhai Maoji Majithiya Ayurved Mahavidyalaya, Yavatmal  
Address  Dayabhai Maoji Majithiya Ayurved Mahavidyalaya and Laxmanrao Kalaspurkar Ayurved Rugnalaya, Department of Shalyatantra OPD No. 05 Yavatmal Shivajinagar, Arni road,Yavatmal-445001

Yavatmal
MAHARASHTRA
445001
India 
Phone  9730195214  
Fax    
Email  nikhilpandule@25gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Laxminiwas R Soni 
Designation  HOD And Professor, Department of Shalyatantra 
Affiliation  Dayabhai Maoji Majithiya Ayurved Mahavidyalaya, Yavatmal  
Address  Dayabhai Maoji Majithiya Ayurved Mahavidyalaya and Laxmanrao Kalaspurkar Ayurved Rugnalaya, Department of Shalyatantra OPD No.05 Yavatmal Shivajinag5ar, Arni road,Yavatmal-445001

Yavatmal
MAHARASHTRA
445001
India 
Phone  9890578425  
Fax    
Email  lrsoni10@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nikhil Shankar Pandule 
Designation  PG scholar M.S.Shalyatantra 
Affiliation  Dayabhai Maoji Majithiya Ayurved Mahavidyalaya, Yavatmal  
Address  Dayabhai Maoji Majithiya Ayurved Mahavidyalaya and Laxmanrao Kalaspurkar Ayurved Rugnalaya, Department of Shalyatantra OPD No. 05 Yavatmal Shivajinagar, Arni road,Yavatmal-445001

Yavatmal
MAHARASHTRA
445001
India 
Phone  9730195214  
Fax    
Email  nikhilpandule@25gmail.com  
 
Source of Monetary or Material Support  
Dmm Ayurved Mahavidyalaya Affiliated With L.K.Ayurved Rugnalaya,Shivajinagar, Arni Road, Yavatmal-445001 
 
Primary Sponsor  
Name  Dmm Ayurved Mahavidyalaya Yavatmal 
Address  Dayabhai Maoji Majithiya Ayurved Mahavidyalaya and Laxmanrao Kalaspurkar Ayurved Rugnalaya, OPD NO. 05 Shalyatantra Department,Yavatmal Shivajinagar, Arni road,Yavatmal-445001 
Type of Sponsor  Other [] 
 
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 Nikhil Shankar Pandule  Dayabhai Maoji Majithiya Ayurved Mahavidyalaya and Laxmanrao Kalaspurkar Ayurved Rugnalaya,Yavatmal   Shalyatantra Department Ipd Room no.25-26 Opd no.05
Yavatmal
MAHARASHTRA 		 9730195214

nikhilpandule25@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Comittee DMM Ayurved Mahavidyalaya,Yavatmal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M479||Spondylosis, unspecified. Ayurveda Condition: PRUSHTHA-GRAHAH (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: sushrut sutrasthan 12/4, Procedure details: A. PURVAKARMA: Proper instrumentation (Agropaharaniyani): ➢ The Agnikarma room will be well prepared with all required Agropaharaniyani described by Acharya Sushruta. ➢ small pieces of Kumari Patra, swab holding forceps, Plot a (gauze piece), Pichu (cotton), gas stove, Betadine solution, etc. will be kept ready for use. ➢ To make the patient fit for Agnikarma (Pre-operative assessment) Radiological and laboratory investigations will be done for fitness and to assess the patient. ➢ Tapta Guda paka will be prepared on a gas stove. ➢ The patient will advised to take boiled rice mixed with curd (Pichchhila, Snigdha, and Laghu Ahara) before the procedure. ➢ Written informed consent of the patient will be taken before going to Agnikarma as it gives information regarding the procedure to the patient and relatives. B. PRADHANA KARMA: ➢ Painting of the local part (i.e. lumbar region) will be done with Betadine solution. ➢ Draping will be done with a sterilized cut sheet. ➢ Gudapaka will be taken in a novel instrument which made up with the help of steel tea strainer. Put a Pichu in that to avoid atidagdha. Also Put thin cloth on lumbar region to avoid direct contact to skin to avoid superficial skin destruction. Put a pressure on instrument with help of half filled sand bottle to heat penetration upto Sira snayu asthi sandhi region. ➢ Valaya type of agnikarma will done for 5sec like this we’ll do agnikarma upto achieving samyak dagdha / sensation of thermal heat conduction upto asthi sandhi region. ➢ After carefully considering the symptoms of the disease, vitals, and the strength of the patient as well as disease and seasons, Agnikarma will be done up to Sira Snyau Sandhi Asthigat Samyak dagdha lakshanas at the lumbar region. ➢ Samyak dagdha lakshanas of Sira, Snayugat dagdha - Krishna Varnata (Black discoloration) Unnata Vranata (Elevated) Srava Sannirodha (Stoppage of discharge) ➢ Asthi,Sandhigatdagdha-Rukshata(Dryness)Arunata(Darkred coloration)Karkashata (Roughness) Sthirata (Stability) C.PASCHATKARMA: ➢ Application of Sheeta Virya Dravyas (immediate cooling agents): After making Samyak Dagdha Vrana fresh pulp of Ghritakumari (Aloe vera) will be applied immediately to subside the burning pain. Samyak Dagdha Vrana will covered with Banana leaf. Patients will be advised to apply ghee twice daily for three days. Patients will be instructed to follow Pathya Apathyas like avoiding drinking cold water, avoiding Dal curry made up of black gram, recipes made up of potato brinjal,etc. at least for one month)
(1) Medicine Name: sahacharadi kashaya, Reference: ashtang hridya chikitsasthan 21/55, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 20(ml), Frequency: bd, Duration: 1 Months
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Patients who are being diagnosed as having Lumbar Spondylosis and fulfilling
the working definition of the study.
2. Gender- Male/Female/Transgender
3. Age group- 30 to 70 years. 
 
ExclusionCriteria 
Details  1. Pitta Prakriti
2. Bhinnakoshtha (injury of internal organs)
3. Daurbalya (weakness)
4. Vrudhha (old people)
5. Antashonita (Internal bleeding)
6. Anudhrita Shalya(foreign body)
7. Bhiru (coward/sensitive persons)
8. Multiple Vrana
9. Balaka (children)
10. Madhumeh (Diabetes Mellitus)
11. Those contraindicated for Swedana
Pandu (Anemia), Atisara (Diarrhea), Kshaya (Emaciation), Guda Bhramsha
(Rectal prolapse), Udara Roga (Ascites), Chhardi Shodhita (After vomiting),
Who has taken alcohol, Oja Kshaya, Sthula (Obese), Ajirna (Indigestion),
Kruddha (angry), Trishna (thirst), Daurbalya and (Weakness), Kshata (Injury),
Timira (Cataract), Kshuda (hunger), Visha Pidita (affected with poison)
12. Fracture of Lumbar vertebrae
13. Pott’s Spine
14. Patients having spinal tumor, malignant diseases of the pelvis, tuberculosis of
Vertebral bodies.
15. R.A. (Rheumatoid arthritis) positive.
16. Other diseases like paralysis, Parkinson’s disease, malignancy.
17. Disc prolapsed causing neuro deficit.
18. Lumbar canal stenosis 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The parameters will be noted down before and after treatment.
The patient will be diagnosed based on symptoms of
Snayusandhiasthiruja (Prishtashoola) explained in Ayurvedic and Modern
texts.
1. Low Back Pain
2. Stiffness of lower back
3. Local tenderness
4. muscle spasm
5. numbness and weakness
6. Painful joint movement 		 0,7th,14th,21th,28th 
 
Secondary Outcome  
Outcome  TimePoints 
1.Range of motion
2.Visual Analog Scale
3.Radiography X-ray lumbosacral ap/lat view
4.sraight leg raise test 		 0,7th,14th,21th,28th 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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)   16/12/2024 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Prishtashoola is an age related and work related painful condition. Sometimes many patients are unable to do their normal routine work. Based on its symptomatology it can be correlated with lumbar spondylosis .Low back pain is a common clinical presentation in musculoskeletal disorders due to spinal pathology.
According to ayurveda prishtashoola is clinal condition that develops when the vitiated vayu becomes localized in kati pradesha. During the process of pathogenesis, kaphavrita vyana vayu obstructs the circulation of rasa and rakta dhatu and gradual structural changes are seen in kati pradesha.
lumbar spondylosis (prishtashoola) is treated with a combination therapy including local treatment of agnikarma by tapta guda paka adjuvant with sahacharadi kashaya internally.
 
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