| CTRI Number |
CTRI/2024/03/064609 [Registered on: 21/03/2024] Trial Registered Prospectively |
| Last Modified On: |
22/11/2024 |
| 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
|
Balamoola rasayana for sciatica |
|
Scientific Title of Study
|
An open labelled randomized controlled clinical study to evaluate the effect of vardhamana balamoola rasayana in gridhrasi w.s.r to sciatica syndrome. |
| 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.Anchumol joseph |
| Designation |
Pg scholar |
| Affiliation |
SDM AYURVEDA MEDICAL COLLEGE AND HOSPITAL UDUPI |
| Address |
Department of kayachikitsa and manasaroga
SDM Ayurveda medical college and hospital
kuthpady,udupi
Udupi
KARNATAKA
574118
India |
| Phone |
9446529173 |
| Fax |
|
| Email |
anchumoljoseph95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Aniruddha |
| Designation |
Associate professor |
| Affiliation |
SDM Ayurveda medical college and hospital kuthpady,udupi |
| Address |
Department of P.G studies in kayachikitsa and manasaroga
SDM ayurveda medical college
kuthpady,udupi
Udupi
KARNATAKA
574118
India |
| Phone |
9446529173 |
| Fax |
|
| Email |
anisaralaya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Anchumol Joseph |
| Designation |
Pg scholar |
| Affiliation |
SDM ayurveda medical college and hospital kuthpady,udupi |
| Address |
Department of kayachikitsa and manasaroga
SDM ayurveda medical college and hospital
kuthpady,udupi
Udupi
KARNATAKA
574118
India |
| Phone |
9446529173 |
| Fax |
|
| Email |
anchumoljoseph95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri dharmasthala manjunatheshwara college of ayurveda and hospital,kuthpady,udupi |
|
|
Primary Sponsor
|
| Name |
Dr Anchumol Joseph |
| Address |
Pg scholar
Department of kayachikitsa and manasaroga
SDM ayurveda medical college and hospital,kuthpady,udupi |
| 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 Anchumol Joseph |
Shri dharmasthala manjunatheshwara college of ayurveda and hospital kuthpady udupi |
Department of kayachikitsa and manasaroga,OPD-7,kayachikitsa
kuthpady,udupi
Udupi
KARNATAKA |
9446529173
anchumoljoseph95@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:M543||Sciatica. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: lashuna rasayana, Reference: ashtanga hridaya rasayana adhyaya, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 48 Days, anupAna/sahapAna: Yes(details: milk), Additional Information: The study includes 1 day mridu virechana followed with 16 days lashuna rasayana course,1 day of mridu virechana after the rasayana course | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: BALAMOOLA RASAYANA, Reference: CHARAKA CHIKITSA STHANA RASAYANA ADHYAYA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 61 Days, anupAna/sahapAna: Yes(details: MILK), Additional Information: The study includes 1 day of mridu virechana followed with 30 days of balamoola rasayana course |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients fulfilling the diagnostic criteria.
2.Patients with or without radiological evidence-MRI,CT of disc prolapse.
3.Patients with or without radiological evidence-MRI,CT of lumbar spondylosis.
4.Patients between the age groups of 18-70 years and of either sex. |
|
| ExclusionCriteria |
| Details |
1.Patients with radiological evidence of fracture of vertebrae, congenital deformities and neoplasm of spine.
2.Pregnancy and lactating mother.
3.Evidence of osteoporosis with BMD less than -2.5
4.Had participated in any clinical trial within 3 months of screening. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
changes in the signs and symptoms of gridrasi.
changes in VAS scale
improvement on the basis of SLR test,bregards test, lasegues sign,bowstring test,femoral nerve stretch test,flip test
improvement in objective parameters like pain-greenough and fraser scoring method,neurological deficit assessment,assessment of functional ability-sugarbaker and barofsky clinical mobility scale,functional disability assessment-oswestry disability assessment questionnaire |
group A- 48 days
group B-61 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| objective parameters |
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/04/2024 |
| Date of Study Completion (India) |
26/08/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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 study is an open labelled randomized controlled clinical study to evaluate the efficacy of balamoola rasayana and lashuna rasayana in vardhamana course in 30 patients diagnosed with gridhrasi/sciatica syndrome. The patients will be randomly divided into 2 groups of 15 each by adapting permuted block randomization method. Group A recruited subjects will be administered with vardhamana lashuna rasayana and group B recruited subjects will be administered with vardhamana balamoola rasayana .Total duration of study will be 48 days for group A and 61 days for group B. study will be conducted at Shri Dharmasthala Manjunatheshwara Ayurveda hospital kuthpady,udupi,karnataka,india. the primary outcome measures will be assesed based on changes in the signs and symptoms of gridrasi,changes in VAS scale, improvement on the basis of SLR test,bregards test, lasegues sign,bowstring test,femoral nerve stretch test,flip test and secondary outcome measures will be assessed based on the improvement in objective parameters like pain-greenough and fraser scoring method,neurological deficit assessment,assessment of functional ability-sugarbaker and barofsky clinical mobility scale,functional disability assessment-oswestry disability assessment questionnaire.Hence an effort has been planned through this clinical study evaluate the effect of vardhamana balamoola rasayana in gridhrasi. |