| CTRI Number |
CTRI/2022/07/043747 [Registered on: 06/07/2022] Trial Registered Prospectively |
| Last Modified On: |
27/05/2023 |
| 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 Rasnadi Guggulu |
|
Scientific Title of Study
|
A Comparative Clinical Study of Agnikarma and Rasnadi Guggulu in Greeva Sandhigata Vata (Cervical 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 Vishal Verma |
| Designation |
Professor |
| Affiliation |
Rishikul Campus, Haridwar, Uttarakhand Ayurved University |
| Address |
OPD No. 7, Department of Shalya Tantra, Rishikul Campus, Haridwar, Uttarakhand Ayurved University
Hardwar
UTTARANCHAL
249201
India |
| Phone |
9719314634 |
| Fax |
|
| Email |
vishalverma100@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishal Verma |
| Designation |
Professor |
| Affiliation |
Rishikul Campus, Haridwar, Uttarakhand Ayurved University |
| Address |
OPD No. 7, Department of Shalya Tantra, Rishikul Campus, Haridwar, Uttarakhand Ayurved University
Hardwar
UTTARANCHAL
249201
India |
| Phone |
9719314634 |
| Fax |
|
| Email |
vishalverma100@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varsha Kuriyal |
| Designation |
P G Scholar |
| Affiliation |
Rishikul Campus, Haridwar, Uttarakhand Ayurved University |
| Address |
OPD No. 7, Department of Shalya Tantra, Rishikul Campus, Haridwar, Uttarakhand Ayurved University
Hardwar
UTTARANCHAL
249201
India |
| Phone |
8755749036 |
| Fax |
|
| Email |
Kuryial.varsha@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD No.7, Department of Shalya Tantra, Rishikul Campus, Haridwar, 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
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Varsha Kuriyal |
Rishikul Campus, Haridwar |
OPD and IPD No. 7, Department of Shalya Tantra, Rishikul Campus, Haridwar, Uttarakhand
Ayurved University
Hardwar
UTTARANCHAL |
8755749036
Kuriyal.varsha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Uttarakhand Ayurved University, Rishikul Campus, Haridwar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M472||Other spondylosis with radiculopathy. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Rasnadi Guggulu, Reference: Yog Ratnakar Vatavyadhi Chikitsa, Route: Oral, Dosage Form: Guggulu , Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: - | | 2 | Comparator Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Sushruta sutra 12, Procedure details: 1. After explaining about the whole procedure of Agnikarma to the patient, consent will be taken.
2. Painful, tender points of the neck will be marked with marker or pen.
3. The procedure will be done with red hot Shalaka at the marked site for just 1 sec.
4. Agnikarma will be done in Bindu manner or in the dots form.
5. Aloe-vera pulp will be applied immediately over the Agnikarma site after the procedure.
Same procedure will be done every 7th day for 28 days)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
a. Patient having clinical features such as pain in cervical region, stiffness, restricted movement of neck, tingling and numbness in upper extremities.
b. X-Ray showing radiological sign for Cervical Spondylosis.
c. Willingness of patient.
|
|
| ExclusionCriteria |
| Details |
Infectious diseases of the Cervical spine.
Fracture or dislocation in cervical region.
Patients with neoplastic growth.
Patients with history of trauma.
Pregnant/lactating women.
Positive cases of COVID- 19.
|
|
|
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 |
| Improvement in Radiological Findings |
28 days |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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)
|
09/07/2022 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
nil |
|
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. Rasnadi
Guggulu is selected from the yogratnakar text
where it is mentioned in the treatment of Sandhigata Vata. AIMS
AND OBJECTIVE
·
To compare the effect of Agnikarma
and Rasnadi Guggulu in the management of cervical spondylosis.
· To decrease the
intensity of pain and stiffness so that the patient can do his routine work
comfortably. |