| CTRI Number |
CTRI/2024/04/065901 [Registered on: 18/04/2024] Trial Registered Prospectively |
| Last Modified On: |
11/04/2024 |
| 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
|
Application of Ayurvedic medicine in the treatment of Vata Kaphaja Gridhrasi (Sciatica) |
|
Scientific Title of Study
|
Efficacy of Dashamoola kashaya with Eranda taila in Vata Kaphaja Gridhrasi with special reference to Sciatica- A Randomized controlled clinical trial |
| 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 Neethu K P |
| Designation |
PG Scholar |
| Affiliation |
KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi |
| Address |
Department of Kayachikitsa
KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9497571949 |
| Fax |
|
| Email |
neethu.kp8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suhas Kumar Shetty |
| Designation |
Professor |
| Affiliation |
KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi |
| Address |
Department of Kayachikitsa
KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9449603234 |
| Fax |
|
| Email |
drsuhasshetty@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suhas Kumar Shetty |
| Designation |
Professor |
| Affiliation |
KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi |
| Address |
Department of Kayachikitsa
KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9449603234 |
| Fax |
|
| Email |
drsuhasshetty@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Shri BMK Ayurveda Hospital and Research centre Shahapur Belagavi |
|
|
Primary Sponsor
|
| Name |
Dr Neethu K P |
| Address |
KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi |
| 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 Neethu K P |
KLE Shri BMK Ayurveda Hospital and Research centre Shahapur Belagavi |
KLE Shri BMK Ayurveda Hospital and Research centre Shahapur Belagavi Dept of Kayachikitsa OPD no 6 OPD no 7
Belgaum
KARNATAKA |
9497571949
neethu.kp8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Research on Human Subjects Shri BMK Ayurveda Mahavidyalaya and Hospital Shahapur Belagavi 590003 |
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: Gandharvahasthadi Kashaya , Reference: Sahasrayogam 1/199, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -warm water), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dashamoola Kashaya , Reference: Charaka sutra sthana 4/38, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -warm water), Additional Information: -(2) Medicine Name: Eranda taila, Reference: Susrutha sutra sthana 45/114, Route: Oral, Dosage Form: Taila, Dose: 2.5(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -Dashamoola kashaya and Eranda taila given together with warm water.
Reference-Cakradatta CikitsSangraha,
Vatavyadhi Chikitsa, 22/58 |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Subjects fulfilling the diagnostic criteria
irrespective of religion, sex, occupation, and
socio-economic status
2 Individuals aged between 20 years to 60 years
3 Unilateral or bilateral radiation of pain in the
sciatica nerve distribution |
|
| ExclusionCriteria |
| Details |
1 History of spinal surgery and vertebral fracture
2 Diagnosed cases of Benign or malignant tumors of
the spine
3 Diagnosed cases of Tuberculosis of the Vertebral
column
4 Diagnosed Patients with major systematic
disorders like uncontrolled Diabetes mellitus
and Cardiovascular diseases
5 Patients having back pain due to non-spinal
illness will be excluded like Urinary tract
infection, Gastrointestinal diseases, and
uterine diseases
6 Pregnant and lactating women
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcomes will be based on Grading Vata-Kaphaja Gridhrasi Symptoms, VAS scale, Tenderness , Roland-Morris Disability Questionnaire,SF-36 QOL
|
0th day 15th day 30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcomes based on SLR test Walking speed time CRP and ESR |
SLR test and Walking speed time (0th day 15th day 30th day) CRP and ESR (0th day and 30th day) |
|
|
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 |
|
Date of First Enrollment (India)
|
25/04/2024 |
| 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
|
Low back pain is an extremely common problem with a reported lifetime prevalence ranging from 49 percentage to 70 percentage An estimated 5 percentage to 10 percentage of patients with low back pain have sciatica The lifetime incidence of sciatica varies from 13 percentage to 40 percentage The corresponding annual incidence of an episode of sciatica ranges from 1 percentage to 5 percentage Sciatica is a debilitating condition resulting from sciatic nerve or nerve root pathology in which the patient experiences pain and or paresthesia in the sciatic nerve distribution or an associated lumbosacral nerve root A sedentary lifestyle stress improper posture heavy lifting continuous jerky movements long traveling are the potential risk factors In contemporary medicine palliative management NSAIDs and analgesics are the mainstays of pharmacotherapy but their long-term use has various adverse effects As a last resort surgical procedures are carried out which are quite expensive with their limitations This painful disorder is equated with Gridhrasi in Ayurveda and Ayurveda offers ample better options in the management of the same Today there is a need to find a drug to manage this condition that is cost effective easily available and has excellent results without hampering the daily routines of the patients In this disease mainly vyana vayu vitiation is observed but kapha is usually associated with dosha So for the treatment of Gridhrasi the drug of choice should have vatashamaka kaphashamaka vatanulomaka dipana pachana and shulaprashamana properties Dashamoola and Eranda are the best choices having such properties to combat this condition Thus Dashamoola Kashaya with eranda taila is taken up for the study to see the effect on symptoms in Vata Kaphaja Gridhrasi |