| CTRI Number |
CTRI/2024/10/074725 [Registered on: 04/10/2024] Trial Registered Prospectively |
| Last Modified On: |
27/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Treatment] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Trial To Study The Effect Of Lashuna Rasayana And Vruddhadaru Rasayana In Patients With Inter Vertebral Disc Prolapse. |
|
Scientific Title of Study
|
A Randomised Comparative Clinical Study To Evaluate The Effect Of Lashuna [Allium sativum linn.] And Vruddhadaru [Argyreia speciosa sweet.] Rasayana In Gridhrasi W.S.R. To Inter Vertebral Disc Prolapse. |
| 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 Akhila K S |
| Designation |
M. D Scholar (Kayachikitsa) |
| Affiliation |
Rajiv Gandhi University Of Health Sciences, Bengaluru |
| Address |
OPD 7,Department Of Kayachikitsa,Shri Dharmasthala
Manjunatheshwara College Of Ayurveda, Hospital and Research centre,Kuthpady
Udupi
Udupi
KARNATAKA
574118
India
Udupi
KARNATAKA
574118
India |
| Phone |
9497461175 |
| Fax |
|
| Email |
akhilaksktkl@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shrilatha Kamath T |
| Designation |
B.A.M.S. M.D (AYU) PhD, Professor and HOD Department of Kayachikitsa and Manasa Roga |
| Affiliation |
Shri Dharmasthala Manjunatheshwara College Of Ayurveda, Hospital And Research Centre, Kuthpady,Udupi |
| Address |
OPD 7,Department Of Kayachikitsa,Shri Dharmasthala
Manjunatheshwara College Of Ayurveda,Hospital and Research centre,Kuthpady,Udupi
Udupi
KARNATAKA
574118
India
Udupi
KARNATAKA
574118
India |
| Phone |
9964899638 |
| Fax |
|
| Email |
shri9503@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shrilatha Kamath T |
| Designation |
B.A.M.S. M.D (AYU) PhD, Professor and HOD Department of Kayachikitsa and Manasa Roga |
| Affiliation |
Shri Dharmasthala Manjunatheshwara College Of Ayurveda, Hospital And Research Centre, Kuthpady,Udupi |
| Address |
OPD 7,Department Of Kayachikitsa,Shri Dharmasthala
Manjunatheshwara College Of Ayurveda,Hospital and Research centre,Kuthpady,Udupi
Udupi
KARNATAKA
574118
India
Udupi
KARNATAKA
574118
India |
| Phone |
9964899638 |
| Fax |
|
| Email |
shri9503@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Dharmasthala Manjunatheshwara Ayurveda Pharmacy,Laxminarayana Nagar P.O.
Kuthpady-574118 Udupi,Karnataka,India |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Akhila K S |
Shri Dharmasthala Manjunatheshwara Ayurveda Hospital, Kuthpady, Udupi |
OPD 7,Department Of Kayachikitsa,Shri Dharmathala
Manjunatheshwara College Of Ayurveda And Hospital,Kuthpady
Udupi
Udupi
KARNATAKA
574118
India
Udupi
KARNATAKA |
09497461175
akhilaksktkl@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Clearance Committee Human |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M958||Other specified acquired deformities of musculoskeletal system. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vruddhadaru Rasayana, Reference: Bhavaprakasa Nigandu, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 10000(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -milk), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Lashuna Rasayana , Reference: Ashtanga Hrudaya, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 10000(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -milk), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients fulfilling the diagnostic measures.
Patients between the age groups of 18-70 years.
Patients with radiological evidence of Inter vertebral disc prolapse in MRI.
Subjects who are willing to sign the informed consent form to participate in the research.
|
|
| ExclusionCriteria |
| Details |
Patients with radiological evidence of fracture of vertebrae, congenital deformities, neoplastic conditions of the spine, infections of the spine, cervical inter vertebral disc prolapse, spondylolisthesis and ankylosing spondylitis.
Any other systemic diseases which will interfere the treatment.
People who are contraindicated for intake of Lashuna.
Pregnancy and lactating mother.
Had participated in any clinical trial within 3 months of screening.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changed in the signs and symptoms of Gridhrasi.
Changes in Sugar baker & Barofsky Clinical Mobility Scale and Oswestry Disability assessment questionnaire score.
Objective
SLR Test
Neurological deficit
|
0 day
17 days
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Objective
SLR Test
Neurological deficit assessed ny Herron and Turners rating. |
0 day
17 days
45 days |
|
|
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)
|
10/10/2024 |
| 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="2"
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
|
This is a Randomised, open label, parallel group study comparing the safety and efficacy of Lashuna rasayana [group A] 10000 mg daily and the Vruddhadaru Rasayana [group B] 10000 mg daily for 15 days for 15 patients in each group and will be conducted in Shri Dharmasthala Manjunatheshwara college of Ayurveda, Hospital and Research centre, Kuthpady, Udupi, Karnataka, India. The primary measures will be assessed through Sugar baker and barofsky clinical mobility scale and Oswestry disability assessment questionnaire and secondary measures assessed through SLR test, and Herron and Turners rating. Hence, this clinical study has planned an effort to prove the efficacy of Lashuna Rasayana and Vruddhadaru Rasayana as effective against Gridrasi W.S.R. to Inter vertebral disc prolapse.
|