“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 yearsâ€
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
DrUddhav Madhukar Gawali
Dayabhai Mavaji Majithiya Ayurveda Mahavidyalaya Yavatmal
