| CTRI Number |
CTRI/2022/06/042988 [Registered on: 02/06/2022] Trial Registered Prospectively |
| Last Modified On: |
20/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic Management of Sciatica |
|
Scientific Title of Study
|
Etiopathogenesis of Gridhrasi w.s.r. to Sciatica and its Upashayatamaka Parikshana with Aabhaadi Churna |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aakanksha Kushwaha |
| Designation |
MD Scholar |
| Affiliation |
Sampurnanand Sanskrit University |
| Address |
Room no 19 Department of Rog Nidana Academic Block Government PG Ayurveda College and Hospital Varanasi Uttar Pradesh 221001
Room no 19 Department of Rog Nidana Academic Block Government PG Ayurveda College and Hospital Varanasi Uttar Pradesh 221001
Varanasi
UTTAR PRADESH
221001
India |
| Phone |
9918390314 |
| Fax |
|
| Email |
aakanksha3455@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Avadhesh Kumar |
| Designation |
Reader and HOD Department of Rog Nidana |
| Affiliation |
Sampurnanand Sanskrit University |
| Address |
Room no 19 Department of Rog Nidan Academic Block Government PG Ayurveda College and Hospital Varanasi
Room no 19 Department of Rog Nidan Academic Block Government PG Ayurveda College and Hospital Varanasi
Varanasi
UTTAR PRADESH
221001
India |
| Phone |
9455262663 |
| Fax |
|
| Email |
dravadheshsaroj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Avadhesh Kumar |
| Designation |
Reader and HOD Department of Rog Nidana |
| Affiliation |
Sampurnanand Sanskrit University |
| Address |
Room no 19 Department of Rog Nidan Academic Block Government PG Ayurveda College and Hospital Varanasi
Room no 19 Department of Rog Nidan Academic Block Government PG Ayurveda College and Hospital Varanasi
Varanasi
UTTAR PRADESH
221001
India |
| Phone |
9455262663 |
| Fax |
|
| Email |
dravadheshsaroj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government PG Ayurveda College and Hospital |
|
|
Primary Sponsor
|
| Name |
Government PG Ayurvedic College and Hospital Varanasi |
| Address |
Room no 19 Department of Rog Nidana Academic block Government PG Ayurvedic College and Hospital Varanasi |
| Type of Sponsor |
Government medical college |
|
|
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 Aakanksha Kushwaha |
Government PG Ayurvedic College and Hospital Varanasi |
Department of PG Studies in Government PG Ayurvedic College and Hospital Varanasi
Varanasi
UTTAR PRADESH |
9918390314
aakanksha3455@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Government PG Ayurvedic College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M959||Acquired deformity of musculoskeletal system, unspecified. Ayurveda Condition: Sciatica, (2) ICD-10 Condition:G55||Nerve root and plexus compressionsin diseases classified elsewhere. Ayurveda Condition: VATAKAPAJA-GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Aabhaadi churna, Reference: Yoga ratnakar vata vyadhi chikitsa, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -luke warm water), Additional Information: -Vata vardhaka ahaara vihaara contraindicated |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having lakshana’s of Gridhrasi as per Ayurvedic texts.
2.Patients having sign and symptoms of Sciatica as per modern medicine.
3.Patients having positive SLR test on examination.
4.Patients diagnosed on the basis of radiological findings.
5.Newly diagnosed cases of Sciatica.
|
|
| ExclusionCriteria |
| Details |
1.Age < 16 yrs and >60yrs.Patients having spinal deformity, spinal tumours, severe traumatic injury.
2.Patients having Spinal injury.
3.Patients having Carcinoma of Spine.
4.Patients having congenital spinal deformity like Spina Bifida.
5.Patients with immunocompromised disease like AIDS, Leukemia, Hepatitis etc.
6.Patients with uncontrolled Diabetes ( > 130mg/dl fasting )( > 180 mg/dl post-prandial )Patients with uncontrolled Hypertension ( > 100mm Hg diastolic)( > 180mm Hg systolic )
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Upshayatmaka Parikshana of Gridhrasi |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Upshayatmaka Parikshana of Gridhrasi |
7 Days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/06/2022 |
| Date of Study Completion (India) |
25/05/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
A minimum of 60 pateints suffering from gridhrasi was selected for the study. Those 60 pateints were selected on the basis of signs and symptoms of gridhrasi. Special proforma was prepared with details of history taking, physical signs, symptoms as mentioned in our classics and allied science, patients were analyzed and selected accordingly. Same treatement wias provided to each pateint. Post test investigation was done after 15 days of treatement. i.e. follow up for 15 days, and treatement schedule for 30 days.Overall effect of therapy suggests mild to moderate improvement in maximum subjects. |