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Clinical Trials/CTRI/2024/03/064857
CTRI/2024/03/064857Not yet recruitingPhase 2/3

“Randomized open controlled clinical study to evaluate the efficiency of ‘Trilawan Pashugandhadi Churna’ orally and ‘Lakshadi Tailam’ locally in the management of Katigraha w.s.r.to Lumber Spondylosis in the age group of 35 to 70 years”

Dayabhai Mavaji Majithiya Ayurveda Mahavidyalaya Yavatmal1 site in 1 country60 target enrollmentStarted: April 5, 2024Last updated:

Trial Snapshot

Phase
Phase 2/3
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
In present clinical trial the patient will be assessed based on the signs and symptoms

Study Overview

Brief Summary

Lumbar Spondylosis may be correlated with Katigraha on the basis of clinical

features of the disease. Katigraha as an independent disease entity for the first time was

described in Gadnigraha in Vatavyadhi chapter³ with the same description made

available in Bhavprakash². Vata Dosha with or without Ama dosha settles in Kati and

causes pain and stiffness in the Katipradrsh (Lumbar Spondylosis).

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
None

Eligibility Criteria

Ages
35.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 1 Age group 35- 70 years irrespective of caste religion socio-economic and educational status 2 The Roland and Morris disability questionnaire if RDQ score more than 5 3 Radiological degenerative changes in Lumbar Spine 4 Patient having sign and symptoms of Katigraha according to classics 5 Patient willing and able to participate in the study 6 Chronic low back pain more than three months.

Exclusion Criteria

  • 1 History of any fracture of vertebral joints and surgical and diagnostic intervention with reference to affected joints will be excluded Gross disability in performing daily normal routine i.e. bedridden patient or confined to a wheelchair will be excluded.
  • 3 Patient with co-morbidities such as gouty arthritis, rheumatoid arthritis or psoriatic arthritis and tubular arthritis 4 Patient with any deformity of Hip or back altering the gait and posture of the patient, ankylosing spondylitis, pelvic i inflammatory disorder 5 Severe alcoholic patient.
  • 6 age group below 35 yrs and above 70 yrs 7 Degenerative disc disease may lead to spinal stenosis (narrowing of the spinal canal), vertebral instability.

Outcomes

Primary Outcomes

In present clinical trial the patient will be assessed based on the signs and symptoms

Time Frame: 0 7th 15th 22nd 29th 36th 45th 60th 75th 90th Days

mentioned described in the Ayurveda texts

Time Frame: 0 7th 15th 22nd 29th 36th 45th 60th 75th 90th Days

(A) SUBJECTIVE CRITERIA

Time Frame: 0 7th 15th 22nd 29th 36th 45th 60th 75th 90th Days

The parameters will be noted down before and after treatment

Time Frame: 0 7th 15th 22nd 29th 36th 45th 60th 75th 90th Days

1 Katishul (Lumbar region)

Time Frame: 0 7th 15th 22nd 29th 36th 45th 60th 75th 90th Days

2 Aakunchan Prasaran Shula (Pain on flexion and extension)

Time Frame: 0 7th 15th 22nd 29th 36th 45th 60th 75th 90th Days

3 Graha (Stiffness)

Time Frame: 0 7th 15th 22nd 29th 36th 45th 60th 75th 90th Days

4 Pindanashtava (Tenderness)

Time Frame: 0 7th 15th 22nd 29th 36th 45th 60th 75th 90th Days

5 Anidra

Time Frame: 0 7th 15th 22nd 29th 36th 45th 60th 75th 90th Days

Secondary Outcomes

  • OBJECTIVE CRITERIA(1 Roland & Morris Disability Questionnaire)

Investigators

Sponsor
Dayabhai Mavaji Majithiya Ayurveda Mahavidyalaya Yavatmal
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

DrUddhav Madhukar Gawali

Dayabhai Mavaji Majithiya Ayurveda Mahavidyalaya Yavatmal

Study Sites (1)

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