A Clinical Trial to Compare the Effectiveness of Dhanwantry Pain Relief Oil, Spray, Patch, and Liniment for Low Back Pain

A multi arm parallel group randomized control clinical trial to evaluate the efficacy of Dhanwantry pain relief liniment, Dhanwantry pain relief transdermal patch, Dhanwantry pain relief Aerosol and Dhanwantry pain relief Oil in low back ache - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/107936

Enrollment

250

Registered

2026-04-09

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

Health Condition 1: M489- Spondylopathy, unspecified

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Patients of any gender in age group 30 to 60 years having mild to moderate low back pain without radiculopathy. (Excluded by MRI Lumbo sacral spine) Patients who are willing to provide informed consent

Exclusion criteria

Exclusion criteria: Patients with severe low back pain who requires acute active management. Patients with H/O Pott s spine, malignancy, trauma, motor- neuron diseases, multiple sclerosis, peripheral vascular disease, pulmonary artery disease cerebro-vascular accident (CVA) Patients who are receiving nonpharmacological interventions like physiotherapy, traction, manual therapy, etc. for the management of pain of low back. Patients with cauda equina syndrome or neurological deficits such as foot drop, limb muscle wasting and bowel/bladder incontinence. Patients with uncontrolled diabetes mellitus (HbA1c More than 8) and uncontrolled hypertension (More than 160/100mm of Hg) Patients with Hepatic Dysfunction (defined as AST and/or ALT more than 2 times of the upper normal limit or Renal Dysfunction (defined as S. creatinine more than 1.2 mg/dl and e GFR more than 90) Pregnant and lactating women Patients who have participated in any other clinical trial during the past two months. Any other condition, which the Investigator thinks, may jeopardize the study

Design outcomes

Primary

Measure	Time frame
Change in Visual Analogue Scale (VAS Scale) for pain at the baseline and at the end of the treatmentTimepoint: 30 days medication and 15 days follow-up without medication	—

Secondary

Measure	Time frame
Improvement in functional disability assessed by Roland Morris Disability Questionnaire at the baseline and at the end of the treatment. Improvement in Quality of Life assessed by short form 36 (SF-36) at the baseline and at the end of the treatment. Safety of Dhanwantry pain relief liniment, transdermal patch and Aerosol assessed by changes in the hematological and biochemical parameters (CBC, LFT and RFT) at the baseline and at the end of the treatment. Frequency of usage of NSAIDS/analgesic medication during the study period. Percentage of occurrence of treatment emergent adverse events Timepoint: 30 days medication and 15 days follow-up without medication	—

Measure

Time frame

Improvement in functional disability assessed by Roland Morris Disability Questionnaire at the baseline and at the end of the treatment. Improvement in Quality of Life assessed by short form 36 (SF-36) at the baseline and at the end of the treatment. Safety of Dhanwantry pain relief liniment, transdermal patch and Aerosol assessed by changes in the hematological and biochemical parameters (CBC, LFT and RFT) at the baseline and at the end of the treatment. Frequency of usage of NSAIDS/analgesic medication during the study period. Percentage of occurrence of treatment emergent adverse events Timepoint: 30 days medication and 15 days follow-up without medication

—

Countries

India

Contacts

Public ContactDr Kanika Aggarwal

Shri Dhanwantry Ayurvedic College and Hospital

pragatidr5@gmail.com7814144288

Outcome results