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A clinical trial on Nochi ver kudineer in the management of Thandagavadham(Lumbar spondylosis)

A PROSPECTIVE OPEN LABELLED NON RANDOMIZED PHASE II CLINICAL TRIAL ON NOCHI VER KUDINEER IN THE MANAGEMENT OF THANDAGAVADHAM(LUMBAR SPONDYLOSIS)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/02/040178
Enrollment
40
Registered
2022-02-10
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: - Health Condition 2: M478- Other spondylosis

Interventions

Intervention1: NOCHI VER KUDINEER: 30-60ml/twice a day(orally) 45 days Control Intervention1: Nil: Nil

Sponsors

Government Siddha Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patient presenting with pain and stiffness in the lumbar region, radiating pain to buttocks and lower limbs, pain aggregating on forward and backward bending 2.SLR test positive patients 3.Patient complaining of back pain functional scale score should be range from below 30 4.Willing to participate in the clinical trial 5.Patient confirmed radiological diagnosis in Lumbar spondylosis

Exclusion criteria

Exclusion criteria: 1.Age below 30 and above 60 2.Tuberculosis of spine 3.SLE 4.Chronic kidney disease 5.Fracture of spine 6.Congenital spinovertebral deformities 7.Mixed connective disease 8.Pregnancy 9.Lactating mother 10.Chronic Liver disease

Design outcomes

Primary

MeasureTime frame
1.Reduction of the symptoms of the pain in lumbar and lowwr limbs 2.Improvement of the range of movements in the lumbar and lower limbs 3.The outcome is aimed at reducing the pain and the range of the movements Good improvement - score 10% or below 10% Moderate improvement - score 10-20% Mild improvement - score 20-30% No improvements score 40%Timepoint: 45 days

Secondary

MeasureTime frame
1.To evaluate the physicochemical, phytochemical bio chrmical analysis of clinical trial drug 2.To evaluate the safety profile for acute and subacute toxicity of the trial drug. 3.To evaluate Antimicrobial activity of trial drug 4.To evaluate the pharmacological analysis of the clinical trial drug 5.To evaluate siddha parameters and compare the (including envagaithervu)changes in Thandagavadham during trial period 6.To evaluate modern parametric changes in Thandagavadham 7.To evaluate the efficacy of Nochi ver kudineer on Thandagavadham by the bio statistical analysisTimepoint: 45 days

Countries

India

Contacts

Public ContactProf Dr A Manoharan MDsPhD

Government Siddha Medical College and Hospital

siddhadrgs21@gmail.com9443358271

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026