| CTRI Number |
CTRI/2025/04/085001 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
11/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Surgical/Anesthesia
Other (Specify) [Therapeutic] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study to compare the Efficacy of Siravedha versus Distal Sodium Channel Block in the
Management of Sciatca (Grudrasi) |
|
Scientific Title of Study
|
A Randomized Controlled Trial to Assess the Efficacy of Siravedha and Distal Sodium Channel Block in the Management of Grudhrasi w.s.r Sciatica
|
| 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 Ritu Singh Thakur |
| Designation |
Pg Scholar |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
Department of Shalya Tantra National Institute of Ayurveda, Deemed To Be
University (De-Novo) Jorawar Singh Gate, Amer Road, Jaipur Rajasthan –Aurveda
Jaipur
RAJASTHAN
302002
India |
| Phone |
07006133129 |
| Fax |
|
| Email |
19ritu23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manorama Singh |
| Designation |
Assistant professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of Shalya Tantra National Institute of Ayurveda, Deemed To Be
University (De-Novo) Jorawar Singh Gate, Amer Road, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
7414810997 |
| Fax |
|
| Email |
doc.manorma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manorama Singh |
| Designation |
Assistant professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of Shalya Tantra National Institute of Ayurveda, Deemed To Be
University (De-Novo) Jorawar Singh Gate, Amer Road, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
7414810997 |
| Fax |
|
| Email |
doc.manorma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalya Tantra National Institute of Ayurveda, Deemed To Be
University (De-Novo) Jorawar Singh Gate, Amer Road, Jaipur Rajasthan –Aurveda |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
National Institute of Ayurveda Deemed To Be University (De-Novo) Jorawar
Singh Gate Amer Road Jaipur Rajasthan – 302002 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Ritu Thakur |
National Institute Of Ayurveda |
Department of Shalya Tantra National Institute of Ayurveda, Deemed To Be
University (De-Novo) Jorawar Singh Gate, Amer Road, Jaipur Rajasthan –Aurveda
Department of Shalya Tantra National Institute of Ayurveda, Deemed To Be
University (De-Novo) Jorawar Singh Gate, Amer Road, Jaipur Rajasthan –Aurveda
Jaipur
RAJASTHAN |
07006133129
19ritu23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee National Institute of Ayurved |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M543||Sciatica, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Distal Sodium Channel Block |
DSCB will be given by infiltration of the drug at |
| Intervention |
Siravedha |
• Torniquet will be applied on affected limb just below the knee to make the vein prominent for easy insertion of cannula.
• Vyadhana site will be properly cleaned using spirit.
• After visible prominent veins of the affected leg, Siravedha using 26G needle with cannula will be performed at Great saphenous vein around the medial malleolus.
• This will be followed by meticulous observation of blood-letting. After 60ml of blood elimination, the needle will be removed followed by pressure bandage of the site.
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age: Patients of either gender between 25-60 years.
Patient having typical clinical feature pertaining to the Sciatica like Constant aching pain felt in the lumbar region and may radiate to the buttock, thigh, calf and foot.
Diagnosed case of Sciatica through Positive Passive SLRT and Buckling test .
Patients having normal CT, BT and Hb above 10gm percent will undergo Siravedha
Patient willing to undergo trial.
|
|
| ExclusionCriteria |
| Details |
• Patients with infectious diseases of spine.
• Patient with infection at the site of DSCB infiltration and Siravedha.
• Patients with past history of or ongoing malignancy or chemotherapy or radiotherapy
• Patients with uncontrolled Diabetes mellitus, Cardiovascular diseases, HIV,Hypertension
• Pregnant or Lactating Females.
• Patients with known hypersensitivity
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Improvement in symptoms of Sciatica.
• Change in VAS, MRSS Score , SLR &Buckling test.
|
BASELINE And 57 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in the quality of life of the patient.( as per SF-12 Questionnaire). |
BASELINE And 57 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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/04/2025 |
| 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 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
|
In Ayurveda Grudhrasi is a type of Vatvyadhi characterized by the clinical features of radiating pain from Spikha (gluteal region) to Pada (foot). Vata and Kapha are predominantly involved dosha in this disease and pain is the cardinal symptom.[i] Based on the symptomatology of Ghrudhrasi it can be corelated with the disease Sciatica in modern parlance.Sciatica occurs due to spinal nerve irritation and is characterized by pain in distribution of sciatica nerve manifesting into chronic radiating low back pain to lower limbs
Distal Sodium Channel Block (DSCB) is a newer concept of pain management which is now being widely practiced. Infiltration of local anesthetic drugs singly or in combination with those that augment or prolong its action around the nerve sheaths, at the most terminal branch along its course
Primary Objective: • To assess & compare the efficacy of Siravedha and DSCB in the management of Sciatica. Secondary Objectives: • To assess the outcome of Siravedha and DSCB. • To assess the patient’s quality of life .(SF-12 Questionnaire) Patients attending the OPD/IPD of the PG Department of Shalya Tantra, NIA hospital will be selected who will be fulfilling the criteria of inclusion, details of the study will be explained, and informed written consent of each patient will be taken on prescribed proforma. After that clinical trial will be executed
Total 40 patients will be selected after detail examination and divided in 2 groups of 20 patients each as per study protocol. All Procedures will be executed done under aseptic condition. |