| CTRI Number |
CTRI/2024/10/075994 [Registered on: 28/10/2024] Trial Registered Prospectively |
| Last Modified On: |
25/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Comparative Clinical Study Of
Agnikarma And Viddhakarma In Cervical Spondylosis |
|
Scientific Title of Study
|
A Comparative Clinical Study Of
Agnikarma And Viddhakarma In Greeva Hundanam |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Laxmi Dixit |
| Designation |
PG Scholar |
| Affiliation |
Quadra Institute of Ayurveda and Hospital |
| Address |
OPD NO-1
Department Of Shalya Tantra
Quadra Institute Of Ayurveda And Hospital
NH58 Roorkee Haridwar Road Near Montfort School.Roorkee 247667
Hardwar
UTTARANCHAL
247667
India |
| Phone |
9219165512 |
| Fax |
|
| Email |
mani.vaibhav30@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhoomi Soni |
| Designation |
Professor |
| Affiliation |
Quadra Institute of Ayurveda and Hospital |
| Address |
OPD NO-1
Department Of Shalya Tantra
Quadra Institute Of Ayurveda And Hospital
NH58 Roorkee Haridwar Road 247667
Hardwar
UTTARANCHAL
247667
India |
| Phone |
9008637659 |
| Fax |
|
| Email |
bhoomi629@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Laxmi Dixit |
| Designation |
PG Scholar |
| Affiliation |
Quadra Institute of Ayurveda and Hospital Roorkee Haridwar |
| Address |
OPD NO-1.
Department Of Shalya Tantra.
Quadra Institute Of Ayurveda And Hospital.
NH58 Roorkee Haridwar Road. 247667
Hardwar
UTTARANCHAL
247667
India |
| Phone |
921916512 |
| Fax |
|
| Email |
mani.vaibhav30@gmail.com |
|
|
Source of Monetary or Material Support
|
| Laxmi Dixit
Department Of Shalya Tantra
Quadra Institute Of Ayurveda And Hospital
NH58 Roorkee Haridwar Road
247667 Uttranchal India |
|
|
Primary Sponsor
|
| Name |
Laxmi Dixit |
| Address |
Department Of Shalya Tantra
Quadra Institute Of Ayurveda And Hospital
NH58 Roorkee Haridwar Road.Near Monfort School 247667 |
| Type of Sponsor |
Other [Self] |
|
|
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 Laxmi Dixit |
Quadra Institute Of Ayurveda And Hospital NH58 Roorkee Haridwar |
OPD NO 1
Department Of Shalya Tantra Quadra Institute Of Ayurveda And Hospital NH58 Haridwar Near Monfort School Roorkee 247667
Hardwar
UTTARANCHAL |
921916512
mani.vaibhav30@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commtee Quadra Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M479||Spondylosis, unspecified. Ayurveda Condition: GRIVAHUNDANAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | raktamokShaNam/ SoNitasrAvaH/ asravisrutiH/ SastravisrAvaNam, रकà¥à¤¤à¤®à¥‹à¤•à¥à¤·à¤£à¤®à¥/ शोणितसà¥à¤°à¤¾à¤µà¤ƒ/ असà¥à¤°à¤µà¤¿à¤¸à¥à¤°à¥à¤¤à¤¿à¤ƒ/शसà¥à¤¤à¥à¤°à | (Procedure Reference: in sushruta sharir, Procedure details: 1.site of Viddhakarma will be cleaned with spirit & Viddhakarma (Venepuncture) will be done with the help of insulin needle on the painful, tender points which was mark by pen or marker.
2. After puncturing, needle will be kept for five seconds & then drawn out from site.
3.If drops of blood will come out it will be allowed to come. Site of Viddhakarma will be clean with Spirit swab.
4.once in a day.(alternate day).for 4 sittings.
)
| | 2 | Comparator Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: sushruta sutra sthan, Procedure details: 1.Painful, tender points of the neck will be marked with marker or pen.
2.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. 3. Gau Ghrit will be applied immediately over the Agnikarma site after the procedure.
4. After completing the procedure, bandaging will be done by applying Madhu & Ghrit.
5.once in a day(alternate day) for 4 sittings
)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Classical signs and symptoms of GreevaHundanam irrespective of their age,sex,occupation.
2 Patients between the age group of 18-60 years.
3 Patient voluntary willing to participate in the Clinical trial.
4 X-Ray showing radio logical signs for Cervical Spondylosis |
|
| ExclusionCriteria |
| Details |
1 Patients of RA, Musculoskeletal disorder other than Greeva Hundanam.
2 Patients of uncontrolled DM and HTN.
3 Patients with any systemic disorder.
4 Patients with any Anatomical abnormalities.
5 Pregnant and Lactating mothers. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
SUBJECTIVE
The assessment of trial will be done based on improvement in the symptoms mentioned as-
1) Neck pain (GreevaShool).
2) Pricking sensation.
3) Stiffness (GreevaStambha).
4) Heaviness.
5) Vertigo (Bhrama) |
• Assessment will be carried out on intermittent days of 1 week i.e – on 1, 3, 5, 7 day to find out the efficacy of Agnikarma and Viddhakarma in Greeva Hundanam. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
OBJECTIVE
1) Range of Motion.
2) Tenderness Over Cervical Region. |
Assessment will be carried out on intermittent days of 1 week i.e – on 1, 3, 5, 7 day to find out the efficacy of Agnikarma and Viddhakarma in Greeva Hundanam.
• 1st follow up - 7 days after completion of treatment.
• 2nd follow up - 15 days after 1st follow up.
• 3rd follow up - 15 days after 2ndfollow up.
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
10/11/2024 |
| 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 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
|
This is a comparative clinical study to revalidate the efficacy of Viddhkarma as Anubhut Chikitsha Prayog in comparison to Agnikarma as Agnikarma is already established treatment in the pain management and to evaluate the efficacy of Agnikarma and Viddhkarma as SadyaShoolHar Chikitsha. For the present research study total 40 patients are selected for clinical trial. In this clinical study, Viddhkarma and Agnikarma will be done on 20-20 patients respectively. Patients will randomly selected with clinical features of GreevaHundanam attending the OPD and IPD of Shalya Tantra dept and other dept of Quadra Hospital irrespective of their gender, race, religion, occupation. This clinical study will be conducted with aim and objective to provide better, safe and effective management to the patient of GreevaHundanam. A detailed performa will be prepared on the basis of Ayurvedic text and allied Sciences. The patient fullfiling the inclusion and exclusion criteria will be registered on this performa and scoring of the different clinical features will be done on the assessment criteria. the observation of the patients will be done before, during and the after completion of trial. Little addition or exclusion may be done as per the necessity of the study.
|