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CTRI Number  CTRI/2023/07/055371 [Registered on: 19/07/2023] Trial Registered Prospectively
Last Modified On: 18/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Treatment of Cervical Spondylosis using Agnikarma and Twagadi gutika 
Scientific Title of Study   A Comparative Clinical Study of Agnikarma and Twagadi Gutika in Greeva Sandhigata Vata(Cervical 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 Vishal Verma 
Designation  Professor 
Affiliation  Rishikul Campus, Uttarakhand Ayurved University, Haridwar 
Address  OPD No. 7, Deptt. of Shalya Tantra, Rishikul Ayurved hospital, Rishikul Campus, Uttarakhand Ayurved University, Haridwar Hardwar UTTARANCHAL 249401 India

Hardwar
UTTARANCHAL
249401
India 
Phone  9719314634  
Fax    
Email  vishalverma100@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vishal Verma 
Designation  Professor 
Affiliation  Rishikul Campus, Uttarakhand Ayurved University, Haridwar 
Address  OPD No. 7, Deptt. of Shalya Tantra, Rishikul Ayurved hospital, Rishikul Campus, Uttarakhand Ayurved University, Haridwar Hardwar UTTARANCHAL 249401 India

Hardwar
UTTARANCHAL
249401
India 
Phone  9719314634  
Fax    
Email  vishalverma100@gmail.com  
 
Details of Contact Person
Public Query  
Name  Akansha Uniyal 
Designation  PG Scholar 
Affiliation  Rishikul Campus, Uttarakhand Ayurved University, Haridwar 
Address  OPD No. 7, Deptt. of Shalya Tantra, Rishikul Ayurved hospital, Rishikul Campus, Uttarakhand Ayurved University, Haridwar Hardwar UTTARANCHAL 249401 India

Hardwar
UTTARANCHAL
249401
India 
Phone  7579490224  
Fax    
Email  akuakansha695@gmail.com  
 
Source of Monetary or Material Support  
Rishikul Campus, Uttarakhand Ayurved University 
 
Primary Sponsor  
Name  Uttarakhand Ayurved University 
Address  Uttarakhand Ayurved University, Harrawala, Dehradun 
Type of Sponsor  Government medical college 
 
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 Akansha Uniyal  Rishikul Campus, Uttarakhand Ayurved University  OPD and IPD No 7 Rishikul Campus, Uttarakhand Ayurved University, Haridwar, Uttarakhand. Hardwar UTTARANCHAL
Hardwar
UTTARANCHAL 		 7579490224

akuakansha695@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Uttarakhand Ayurveda University, Rishikul Campus, Haridwar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M478||Other spondylosis. Ayurveda Condition: SANDHIGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: Sushrut Samhita, Sutra Sthan, Chapter 12, Agnikarma vidhi adhyaya, Procedure details: Materials:Panchdhatu Shalaka, gas cylinder, burner, pulp of Ghritkumari Patra, Madhu & Ghrit.Method:a. After explaining about the whole procedure of Agnikarma to the patient, consent will be taken.b. Painful, tender points of the neck will be marked with marker or pen.c. The procedure will be done with red hot shalaka at the marked site for just 1 second. Agnikarma will be done in Bindu manner or in the dots form.d. Aloe-vera pulp will be applied immediately over the Agnikarma site after the pro)
2Intervention ArmDrugClassical(1) Medicine Name: Twagadi Gutika, Reference: Gadhnigrah- Pratham Prayog Khand, Chaturth Gutikadhikar, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1) Patients having clinical features such as pain in cervical region, stiffness, restricted movement of neck, tingling sensation and numbness in upper extremities.
2) X-Ray showing radiological signs for Cervical Spondylosis. 
 
ExclusionCriteria 
Details  1) Infectious diseases of the Cervical spine.
2) Fracture or dislocation in cervical region.
3) Patients with cervical myelopathy, neoplastic growth or history of trauma.
4) Pregnant/lactating women.
5) RA factor positive cases. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
It will be assessed on the basis of relief in
following parameters -
• Neck Pain
• Radiation of Pain
• Stiffness
• Weakness
• Vertigo
• Tenderness over cervical region
• Movements of the neck 		 28 days 
 
Secondary Outcome  
Outcome  TimePoints 
Improve in radiological findings  28 days 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
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)   27/07/2023 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Sandhigata Vata is one of the commonest joint disorders, broadly
described under Vata Vyadhi which effect Musculo-skeletal system of the
body. Sandhigata Vata is a disease of Sandhi (joint) with symptoms of
Sandhi Shoola, Sandhi Shotha, Vedana during Akunchana, Prasarana and
in a later stage Hanti Sandhigatah.When Greeva Pradesh is affected, it
termed as Greeva Sandhigata Vata or Cervical Spondylosis. Acharya
Sushruta has mentioned Agnikarma having Vata-kaphahara property like
Ushna, Sukshma, Ashukari Guna. So, it has been chosen to manage
Sandhigata Vata. As Agnikarma may be effectively helpful to relieve the
pain and muscle spasm instantly so it is used to manage cervical
spondylosis. Twagadi Gutika is described in Gadhnigrah, in the management of Vatavyadhi.
AIM AND OBJECTIVES
1) To compare the efficacy of Agnikarma and Twagadi Gutika in Cervical Spondylosis.
2) To decrease the intensity of pain, stiffness and weakness so that the patient can do his routine work comfortably.
 
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