| CTRI Number |
CTRI/2024/05/067162 [Registered on: 10/05/2024] Trial Registered Prospectively |
| Last Modified On: |
08/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Pain management of Grivasandhigatavata by modified Shringa yantra. |
|
Scientific Title of Study
|
Clinical efficacy of Raktamokshana by modified shringa yantra(cupping therapy) in the management of Grivasandhigatavata wsr 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 Ankita Padhi |
| Designation |
MS Scholar |
| Affiliation |
Gopabandhu Ayurveda Mahavidyalaya VIP Road Puri Odisha |
| Address |
Post graduate department of Shalyatantra
Gopabandhu Ayurveda Mahavidyalaya VIP Road Puri Odisha
Puri
ORISSA
752002
India |
| Phone |
7854020520 |
| Fax |
|
| Email |
ankitapadhi100@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Ranjan Kumar Kasta |
| Designation |
Professor and HOD |
| Affiliation |
Gopabandhu Ayurveda Mahavidyalaya VIP Road Puri Odisha |
| Address |
Post graduate department of Shalyatantra
Gopabandhu Ayurveda Mahavidyalaya VIP Road Puri Odisha
Puri
ORISSA
752002
India |
| Phone |
9439809240 |
| Fax |
|
| Email |
drrkkasta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Ranjan Kumar Kasta |
| Designation |
Professor and HOD |
| Affiliation |
Gopabandhu Ayurveda Mahavidyalaya VIP Road Puri Odisha |
| Address |
Post graduate department of Shalyatantra
Gopabandhu Ayurveda Mahavidyalaya VIP Road Puri Odisha
ORISSA
752002
India |
| Phone |
9439809240 |
| Fax |
|
| Email |
drrkkasta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gopabandhu Ayurveda Mahavidyalaya VIP Road Puri Odisha 752002 |
|
|
Primary Sponsor
|
| Name |
Dr Ankita Padhi |
| Address |
Post graduate department of Shalyatantra
Gopabandhu Ayurveda Mahavidyalaya VIP Road Puri Odisha |
| 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 |
| Prof Dr Ranjan Kumar Kasta |
Gopabandhu Ayurveda Mahavidyalaya Puri |
OPD & IPD Of Post graduate department of Shalyatantra
VIP Road Puri Odisha 752002
Puri
ORISSA |
9439809240
drrkkasta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Gopabandhu Ayurveda Mahavidyalaya and Hospital Puri Odisha- 752002 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M479||Spondylosis, unspecified. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
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: Sushruta Samhita, Procedure details: In this procedure we have to study the efficacy of modified shring yantra(Cupping therapy) in the management of Grivasandhigata Vata WSR to Cervical Spondylosis.We should apply this therapy on every 15days for total 45 days.)
| | 2 | Intervention 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: Sushruta Samhita, Procedure details: In this procedure we have to study the efficacy of modified shring yantra(Cupping therapy) in the management of Grivasandhigata Vata WSR to Cervical Spondylosis.We should apply this therapy on every 15days for total 45 days.)
|
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Cervical Spondylosis
Age group between 16-70 years |
|
| ExclusionCriteria |
| Details |
Pregnant/lactating woman.
Patients group of age below 16 years and above 70 years.
Patients suffering from pathological condition like Bone tumor, Tuberculosis spine etc.
Uncontrolled diabetes mellitus.
History of injury to cervical spine.
AIDS, HepatitisB
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To develop the ayurvedic concepts in the management of Grivasandhigata Vata (Cervical Spondylosis).
|
3 sittings on a gap of 15 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To promote cupping therapy in the daily clinical practices. |
45 days |
|
|
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
30/05/2024 |
| 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="0"
Months="1"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Total 40 patients will be selected for the study. Selected case will be done clinical examinations and pathological investigations to assess the present condition. 1. A total of 40 diagnosed patients of Grivasandhigata Vata (Cervical Spondylosis will be selected from OPD /IPD of Shalya Tantra, Gopabandhu Ayurveda Mahavidyalaya & Hospital Puri, &District Headquarter Hospital, Puri, Odisha. 2. The patients shall also be collected from the special camps organized outside the city & they would be admitted in Gopabandhu Ayurveda Hospital Puri, Odisha. |