| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M47||Spondylosis. Ayurveda Condition: VISVACI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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: | | 2 | Comparator Arm | Drug | Classical | | (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: - |
|
|
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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. |
|
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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 |