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CTRI Number  CTRI/2025/02/081304 [Registered on: 25/02/2025] Trial Registered Prospectively
Last Modified On: 24/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Role of Ajmodadi Vataka in Vishwachi (Cervical Spondylosis) 
Scientific Title of Study   A Randomized Open Label Controlled Clinical Study to Evaluate the Efficacy of Ajmodadadi Vataka in the Management of Vishwachi w.s.r. to 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. Kusum Verma 
Designation  PG Scholar 
Affiliation  Jammu Institute of Ayurveda and Research Jammu 
Address  Department of PG Studies in Kaya Chikitsa Jammu Institute of Ayurveda and Research Kot Bhalwal Road Nardani Jammu and Kashmir

Jammu
JAMMU & KASHMIR
181123
India 
Phone  7696878521  
Fax    
Email  kvkusumverma@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Nitin Mahajan 
Designation  Professor 
Affiliation  Jammu Institute of Ayurveda and Research Jammu 
Address  Department of PG Studies in Kaya Chikitsa Jammu Institute of Ayurveda and Research Kot Bhalwal Road Nardani Jammu and Kashmir

Jammu
JAMMU & KASHMIR
181123
India 
Phone  9419119123  
Fax    
Email  drnitinmahajan1608@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nitin Mahajan 
Designation  Professor 
Affiliation  Jammu Institute of Ayurveda and Research Jammu 
Address  Department of PG Studies in Kaya Chikitsa Jammu Institute of Ayurveda and Research Kot Bhalwal Road Nardani Jammu and Kashmir

Jammu
JAMMU & KASHMIR
181123
India 
Phone  9419119123  
Fax    
Email  drnitinmahajan1608@gmail.com  
 
Source of Monetary or Material Support  
Jammu Institute of Ayurveda and Research Jammu 181123 India 
 
Primary Sponsor  
Name  Jammu Institute of Ayurveda and Research Jammu 
Address  Kot Bhalwal, Nardani, Jammu, Jammu and Kashmir - 181123 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
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 Kusum Verma  Jammu Institute of Ayurveda and Research, Jammu  Room No. 102,First Floor, Department of Kaya Chikitsa, Jammu Institute of Ayurveda and Research
Jammu
JAMMU & KASHMIR 
7696878521

kvkusumverma@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Jammu Institute of Ayurveda and Research, Jammu  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M47||Spondylosis. Ayurveda Condition: VISVACI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: AJMODADI VATAKA, Reference: BHAVPRAKASH CHIKITSA PRAKARAN, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: HOT WATER), Additional Information:
2Comparator ArmDrugClassical(1) Medicine Name: Trayodasang Guggulu, Reference: Bhaishajya Ratnavali, Vatavyadhi Adhikar Adhaya, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Hot Water), Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients with age group between 20 to 70 years.
2. Patients with either gender irrespective of caste, creed and religion.
3. Patient representing signs and symptoms of Vishwachi who are willing to participate in study.
 
 
ExclusionCriteria 
Details  1. Patients having the history of systematic disease like Diabetes Mellitus, Hypertension, Tuberculosis and other chronic diseases.
2. Impaired Renal function and abnormal liver function.
3. History of major trauma causing cervical vertebra fracture, traumatic injury of cervical spine, cervical myelopathy.
4. Patient suffering from neoplastic and infective disorders.
5. Pregnant and lactating women. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Subjective Parameters

Ruk - Pain

Toda - Pricking Sensation

Gourawa

Arochaka - No desire to eat

Spandana

Objective Parameters

Range of Motion of Neck

Lhermitte Test

Spurling Test 
Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Objective Parameters

Range of Motion of Neck

Range of Motion of Shoulder  
Baseline, 15th Day, 30th Day, 45th Day 
 
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 3 
Date of First Enrollment (India)   07/03/2025 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Today we are living in 21st century, a century of workaholic generation, a generation which is mostly dependent on technology and spend the most time of their day in using gadgets, mobiles, working on computers, long hour of travelling and busy work schedules of corporate world. Due to this hectic, unoriented and fast life style people are not able to follow basic physical, dietary as well as mental healthy habits. These unhealthy habits increasing degenerative disease (Dhatukshaya) of spine especially of cervical region.

Vishwachi, which is one of the Vata Nanatmaja Vatavyadhi. It affects the neck and upper extremities leading to decreased efficacy with dysfunctioning of neck & extremities with signs and symptoms like Ruka, Toda, Stambha, Karmakshaya 1and Chestapaharana of Bahu2 as explained by different Acharya’. Dalhana also opines that the condition resembles Gridhrasi which affects the lower limb, and of two types, Vataja and Vata Kaphaja3

Vishwachi affects from Bahuprustha (the back aspect of the upper limb) to Talapratayangulinam because of Vata Dosha in all the Kandra (Tendon) of the Hasta (Arm) and Bahu (upper arm or shoulder), Bahu Chestha Apaharani (dysfunction of arm and shoulder). So radiating pain and restricted movement is main symptom of Vishwachi. It means the condition in which Vata dosha gets aggravated from the posterior part of fingers and anterior part of Prakoshtha and Kandara ,which reduces the motor neuron functions of the hand ,is called Vishwachi. It occurs due to variations in Ahara and Vihara like Vataprokopa Ahara and Vihara as Rukshahara,Ativyama,Vegadharana are the causative factors for Vishwachi.4-6

Vishwachi is similar to that of Cervical Spondylosis which is degenerative condition (Dhatukshaya) of the cervical spine. Further chronic stage of this condition which leads to cervical radiculopathy.

 Shamana Ausadhi is mentioned in our classical text for the management of Vishwachi. In the present Ajmodadi Vataka which is mentioned in Bhavaprakash used as Shamana Ausadhi, is taken to assess its efficacy on Vishwachi w.s.r to Cervical Spondylosis and compared with the effect of Trayodasang Guggulu. Most people with spondylotic changes of the cervical spine on radiographic imaging remain asymptomatic, with 25% of individuals under the age of 40, 50% of individuals over the age of 40, and 85% of individuals over the age of 60 showing some evidence of degenerative changes. The most frequently affected levels are C6-C7, followed by C5-C6. Symptomatic cervical spondylosis most commonly presents as neck pain. In the general population, the point prevalence of neck pain ranges from 0.4% to 41.5%, the 1-year incidence ranges from 4.8% to 79.5%, and lifetime prevalence may be as high as 86.8%. According to the Global Burden of Disease 2015, low back and neck pain remain the leading cause of years lived with disability (YLD) and the fourth leading cause of disability-adjusted life.7-9


 
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