| CTRI Number |
CTRI/2025/05/086806 [Registered on: 13/05/2025] Trial Registered Prospectively |
| Last Modified On: |
13/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of Adjuvant AYUSH and TENS therapy among Spinal Injury patients |
|
Scientific Title of Study
|
A Pragmatic Clinical Trial (PrCT) to study the efficacy of adjuvant Neuromodulation Vs AYUSH therapy in surgically operated patients of traumatic thoracolumbar injury |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Suyash Singh |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Raebareli |
| Address |
Department of Neurosurgery
Room Number 332, Third Floor
AIIMS Hospital Building
Dalmau Road
Munshiganj
AIIMS Raebareli
229405
Uttar Pradesh
Rae Bareli
UTTAR PRADESH
229405
India |
| Phone |
6393627740 |
| Fax |
|
| Email |
drsuyashsingh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shreyajit Mishra |
| Designation |
MS General Surgery Student |
| Affiliation |
AIIMS Raebareli |
| Address |
Department of Neurosurgery
Room Number 332, Third Floor
AIIMS Hospital Building
Dalmau Road
Munshiganj
AIIMS Raebareli
229405
Uttar Pradesh
Rae Bareli
UTTAR PRADESH
229405
India |
| Phone |
6393627740 |
| Fax |
|
| Email |
shreyajit23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Suyash Singh |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Raebareli |
| Address |
Department of Neurosurgery
Room Number 332, Third Floor
AIIMS Hospital Building
Dalmau Road
Munshiganj
AIIMS Raebareli
229405
Uttar Pradesh
Rae Bareli
UTTAR PRADESH
229405
India |
| Phone |
6393627740 |
| Fax |
|
| Email |
drsuyashsingh@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Raebareli |
|
|
Primary Sponsor
|
| Name |
AIIMS Raebareli |
| Address |
Department of General Surgery
AIIMS Raebareli
Dalmau Road
Munshiganj
Raebareli
229405
Uttar Pradesh (India) |
| 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 Suyash Singh |
AIIMS Raebareli |
Department of AYUSH and Neurosurgery
AIIMS Raebareli
Dalmau Road
Munshiganj
Raebareli
Rae Bareli
UTTAR PRADESH |
6393627740
drsuyashsingh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Raebareli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M961||Postlaminectomy syndrome, not elsewhere classified. Ayurveda Condition: KATIKATARUNA-MARMAVIDDHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | TENS | Group A: Surgically operated patients with Adjunct Neuromodulation: TENS therapy will be used on Day-1 post-operative (T0) at least once per day for twice (morning and evening) 45-minute treatment session. TrEMG will be used once in the intra-operative period only. | | 2 | Comparator Arm (Non Ayurveda) | | - | NO Adjuvant | Group C: Surgically operated patients without any adjuncts i.e. our own historical data from Patient file and HMIS records of the operated patients of thoracolumbar spine injury. | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Matra Basti (Medicated oil enema), Reference: https://journals.lww.com/ijai/fulltext/2021/02020/effect_of_matravasti__medicated_oil_retention.4.aspx, Route: Rectal, Dosage Form: Dravaka, Dose: 50(ml), Frequency: od, Bhaishajya Kal: Samudga, Duration: 1 Weeks, anupAna/sahapAna: No, Additional Information: - |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Our study comprises of two intervention arms and one historical data arm as follows
(a) Group A: Surgically operated patients with Adjunct Neuromodulation: TENS therapy will be used on Day-1 post-operative (T0) at least once per day for twice (morning and evening) 45-minute treatment session. TrEMG will be used once in the intra-operative period only.
(b) Group B: Surgically operated patients with AYUSH Therapy: The patients in this group will be under supervision of AYUSH doctors after surgery. Patients will receive AYUSH ministry certified oral medicines and targeted therapies. Following post operative protocol will be used as adjunct
|
|
| ExclusionCriteria |
| Details |
Randomisation will be done by Nursing Officer of ward at the time of taking consent (one-day prior to surgery). We will be using computer generated random numbers (Well Equi-distributed Long-period Linear; based on linear recurrences modulo 2 over a finite binary field F2) for simple randomisation (https://leventozturk.com/engineering/random/). Nursing Officer will just write Group name (‘A’ or ‘B’) over the file and further adjunct protocol will be followed as per methodology. The data collection will be done by blinded third researcher (SM) and data analysis will be done by blinded fourth researcher (SM, BN). The independent third and fourth researchers are not directly involved in surgical procedure. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Evaluate the clinical advantage of adjunct Triggered Electromyography (TrEMG) and TENS therapy in the operated patients of thoracolumbar spine injury.
2. Evaluate the clinical advantage of adjunct Ayurveda medicine plus Abhyangam therapy in the operated patients of thoracolumbar spine injury
3. Compare the neurological outcome and Quality of life (QoL) among two treatment options.
|
Time line Details
T0 One day before surgery
T1 Post operative day-1
T2 Post operative day -7
T3 At 6th week of surgery
T4 At 3-months of surgery
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the surgical outcome of thoracic lumbar spine surgery operated in our institute. |
Time line Details
T0 One day before surgery
T1 Post operative day-1
T2 Post operative day -7
T3 At 6th week of surgery
T4 At 3-months of surgery
|
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2025 |
| 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
|
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Brief Summary
|
This research project’s aim is to investigate the adjunct
role of neuromodulation and AYUSH therapy and predictors of poor outcome in TSI.
The study will use a pragmatic clinical design, involving patients having
unstable spinal injury and is being operated for same, admitted to a level 1 center of excellence,
where TSI is confirmed by CT scan and neurologically (as per AO system of
classification). The study will compare the efficacy of post-operative adjunct
TENS therapy with intra-operative TcEMG stimulation Vs Ayurveda oral medicine
and therapy. The study will also assess the clinical outcomes of the patients
using QoL Sci and Barthel rehabilitation scores. The study will analyse the
correlation across various groups and the outcome measures, as well as the
potential confounding factors, like age, along with gender, along with injury
severity, surgical treatment, and medical administration. The study will
contribute to the understanding of the pathophysiology and prognosis of
electrophysiology, and potentially therapeutic targets for AYUSH therapy.
|