| CTRI Number |
CTRI/2023/05/052859 [Registered on: 18/05/2023] Trial Registered Prospectively |
| Last Modified On: |
18/05/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to evaluate the efficacy of Ayurvedic treatment protocol in lumbar disc herniation with radiculopathy |
|
Scientific Title of Study
|
“A randomized controlled clinical trial to evaluate the efficacy of Ayurveda treatment protocol in lumbar disc herniation with radiculopathy†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aswani P S |
| Designation |
Research Officer (Ayurveda) |
| Affiliation |
Central Council for Research in Ayurvedic Sciences |
| Address |
National Ayurveda Research Institute for Panchakarma, Cheruthuruthy
Thrissur
KERALA
679531
India |
| Phone |
9447508751 |
| Fax |
|
| Email |
aswanibalaji2012@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aswani P S |
| Designation |
Research Officer (Ayurveda) |
| Affiliation |
Central Council for Research in Ayurvedic Sciences |
| Address |
National Ayurveda Research Institute for Panchakarma, Cheruthuruthy
Thrissur
KERALA
679531
India |
| Phone |
9447508751 |
| Fax |
|
| Email |
aswanibalaji2012@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aswani P S |
| Designation |
Research Officer (Ayurveda) |
| Affiliation |
Central Council for Research in Ayurvedic Sciences |
| Address |
National Ayurveda Research Institute for Panchakarma, Cheruthuruthy
Thrissur
KERALA
679531
India |
| Phone |
09447508751 |
| Fax |
|
| Email |
aswanibalaji2012@gmail.com |
|
|
Source of Monetary or Material Support
|
| CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES Ministry of AYUSH, Government of India |
|
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Primary Sponsor
|
| Name |
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES Ministry of AYUSH, Government of India |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Avum Homeopathy Anusandhan Bhavan
No.61-65, Institutional Area, Opp. D Block, Janakpuri,
New Delhi - 110058 ( India ) |
| Type of Sponsor |
Research institution |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aswani P S |
NATIONAL AYURVEDA RESEARCH INSTITUTE FOR PANCHAKARMA CHERUTHURUTHY |
Hospital section
6th floor
Room no: A605
Thrissur
KERALA |
9447508751
aswanibalaji2012@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G544||Lumbosacral root disorders, not elsewhere classified. Ayurveda Condition: GRUDHRASI, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | mAdhutailikabastiH, माधà¥à¤¤à¥ˆà¤²à¤¿à¤•à¤¬à¤¸à¥à¤¤à¤¿à¤ƒ | (Procedure Reference: SOP OF PANCAKARMA NARIP CHERUTHURUTHY, Procedure details: Madhutailika vasti will be administered for a period of 7 days following classical method of administration)
(1) Medicine Name: Madhutailika vasti, Reference: Su Ci 38/100-101, Route: Rectal, Dosage Form: Not Applicable, Dose: 800(ml), Frequency: od, Duration: 7 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Rasnasaptakam kwath, Reference: AFI part 2 -4:20, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 96(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Shunti Churna), Additional Information: - | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vatari guggulu, Reference: API Part 1 Volume 8, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Kwath), Additional Information: - | | 4 | Intervention Arm | Procedure | - | aBya~ggaH, अà¤à¥à¤¯à¤‚ग | (Procedure Reference: SOP PANCAKARMA OF NARIP CHERUTHURUTHY, Procedure details: Abhyanaga with luke warm Tila taila will be performed for 30 minutes for 30 days)
(1) Medicine Name: Tila taila, Reference: A.H . Su 5/ 55-56, Route: Topical, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Duration: 30 Days | | 5 | Comparator Arm (Non Ayurveda) | | - | Conventional Allopathic treatment | Diclofenac sodium tablet 50-75 mg bid a/f with lukewarm water for seven days, and if painful episodes occur during the follow-up period. | | 6 | Comparator Arm (Non Ayurveda) | | - | Conventional Allopathic treatment | Pantoprazole tablet 40 mg (1-0-0),30 minutes b/f with luke warm water, for seven days and while taking diclofenac tab. | | 7 | Comparator Arm (Non Ayurveda) | | - | Conventional Allopathic treatment | Gabaneuron tab 300 mg bid a/f with lukewarm water- for30 days | | 8 | Comparator Arm (Non Ayurveda) | | - | Conventional Allopathic treatment | Local Application-Diclofenac gel-SOS-for 30 days | | 9 | Comparator Arm (Non Ayurveda) | | - | Physiotherapy | Physiotherapy- Pelvic traction -Continuous/Intermittent as per severity - for seven days |
|
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Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants of any gender in the age group 25-55 years.
2. Subjects having Oswestry disability index (ODI) score between 21% -60 %.
3. Participants diagnosed with lumbar disc herniation with radiculopathy with unilateral radiating pain (either left or right lower limb) due to Intervertebral disc herniation confirmed by MRI (disc herniation between L3 and S1 level; at single or double level) provided no neurologic deficit is evident
4. Positive straight leg raise test (ipsilateral or contralateral pain in the leg, buttock, or back at 70 degrees or less of leg elevation, and the pain is typically worsened by dorsiflexion of ankle or neck flexion after slowly lowering the leg until the patient no longer feels pain
5. Willingness to provide informed consent and adhere to the study protocol for 2 months.
|
|
| ExclusionCriteria |
| Details |
1. Indication for surgical intervention for disc herniation like severe motor deficit (motor power of lower limbs assessed through Medical Research Council Manual Muscle Testing scale ≤3), severe spinal stenosis; excruciating pain that cannot be managed by conservative treatment, foraminal stenosis, conjoint nerve root, perineural cyst etc.
2. Patients who have received non pharmacological interventions like physiotherapy, traction, manual therapy, etc. for the management of lumbar disc herniation in last 3 months.
3. History of or evidence of any of the following - Osteoporotic lumbar fracture, presence of inflammatory or infective diseases that affect spinal morphology, such as ankylosing spondylitis, Spondylodiscitis or inflammatory spondylitis, spondylolisthesis, Pott’s spine, Pyriformis syndrome, sacro-iliitis, neural foraminal stenosis
4. History of spinal surgery in last 2 years or having epidural fibrosis.
5. Patients with caudaequina syndrome or neurological deficits such as foot drop, limb muscle wasting and bowel/bladder incontinence or Non-ambulatory patients with Monoplegia/ Paraplegia/ Hemiplegia.
6. Evidence or history of spinal trauma or Spinal Malignancy.
7. Presence of other medical condition presenting with numbness and pain in lower extremities, such as diabetic polyneuropathy and peripheral vascular disease, Motor Neuron Disease, Multiple Sclerosis, Stroke or Cognitive Impairment.
8. Major coexisting medical condition such as cancer, chronic obstructive pulmonary disease, cardiovascular disease and severe hepatic and renal dysfunction.
9. Peptic ulcer disease, GI haemorrhage/perforation.
10. Obesity (BMI greater than or equal to 30 kg/m2).
11. Metallic implants like pace makers, hearing aid implants etc. and other contraindications for MRI.
12. Any other condition that as per the investigator is contraindicated for the intervention in the study.
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Method of Generating Random Sequence
|
Random Number Table |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Oswestry Disability Index Version 2.0 (ODI)
|
The clinical assessment will be done on base line, after completion of the IPD treatment on 8 th day, and during follow-ups (30 th day and 60th day). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Assessment of QOL using - Short form 36 (SF-36)
2. Occurrence of adverse events
3. Need of Rescue analgesic medication
|
2 months |
|
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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
|
Phase 3 |
|
Date of First Enrollment (India)
|
07/09/2023 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
After completion of the trial,the outcome of the study will be published in an indexed journal. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is planned as Randomised Controlled trial to evaluate the efficacy of Ayurveda treatment protocol in Lumbar disc herniation with Radiculopathy. The protocol of the study was submitted to CCRAS and Institutional Ethics Committee and got approved. The primary objective of the study is the Clinical evaluation of Ayurveda treatment protocol compared to standard care in lumbar disc herniation with radiculopathy on pain and functional disability and the secondary objectives of the study are to evaluate the change in the quality of life of subjects with lumbar disc herniation with radiculopathy, compare the need of analgesic medication and the clinical evaluation of the safety of Ayurveda treatment protocol compared to standard care in lumbar disc herniation with radiculopathy. Participants will be selected from OPD of National ayurveda Research Institute for Panchakarma, Cheruthuruthy. All the patients with features of lumbar radiculopathy will be screened based on inclusion and exclusion criteria. Those subjects having ODI score between 21% to 60 % will be subjected to MRI lumbosacral spine for confirmation of the diagnosis. Blood investigations like complete hemogram, LFT, RFT, CRP will be performed at screening and after study period. Blood investigations like HbA1C, RBS, RA Factor and HLAB27 will be performed only at screening to rule out any inflammatory pathology. The Sample of size of the study is 80. The selected subjects will be randomized into groups A and B, using the random number table technique. The intervention for group A will be with Ayurveda treatment protocol and group B will be with standard care. The baseline assessment of all the selected participants will be performed and they will be admitted to IPD, National ayurveda Research Institute for Panchakarma, Cheruthuruthy. The clinical assessment will be done on base line, after completion of the IPD treatment, and during follow-ups (30th day and 60 th day). The intervention period of the study is 2 months. Primary outcome measure of the study is Numeric pain assessment scale- VAS scale, Oswestry Disability Index Version 2.0 (ODI) and secondary outcome measure is Assessment of QOL using - Short form 36(SF-36). |