Clinical Study of Three Different Topical Formulations in Backache.

A Randomized, Single Blind, Prospective, Multi-center, Phase II, Clinical Study to evalaute efficacy and safety of three different topical formulations in subjects suffering from Backache. - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/03/006702

Enrollment

Registered

2016-03-03

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Backache

Interventions

Intervention1: CT 64: It contains Mentha, Gaultheria fragrantissima Dosage and treatment duration: Apply sufficient quantity on the Back twice daily for 28 days Control Intervention1: CT 46: It contai

Eligibility

Inclusion criteria

Inclusion criteria: 1.Low Back Pain without any serious medical/surgical condition for a minimum period of six months. 2.History of Low Back Pain requiring the use of NSAIDs Acetaminophen, or another analgesic agent on a regular basis for at least six months before the screening visit 3.Subjects not having severe Lumbar joint deformity 4.Subjects signing written informed consent and ready to comply with the protocol requirement 5.Subjects with pain VAS > 40 mm on weight bearing activities

Exclusion criteria

Exclusion criteria: 1.Rheumatoid arthritis, gout, pseudo gout, inflammatory arthritis, Pagets disease of bone, chronic pain syndrome, fibromyalgia, or another major joint disease 2.Subjects requiring Spine surgery within 6 months of screening 3.Use of any other investigational drug within 1 month prior to randomization 4.Subjects having uncontrolled diabetes mellitus, tuberculosis, HIV, Ischemic Heart Disease 5.Known other active and serious medical or surgical disease 6.Pregnancy and Lactation 7.Known hypersensitivity to ingredients used in study drug

Design outcomes

Primary

Measure	Time frame
1.Assessment of Backache on VAS 2.Assessment of Backache on Bournemouth Questionnaire Timepoint: Day 7, Day 14, Day 21, Day 28	—

Secondary

Measure	Time frame
1. Time of onset of action in relieving painful symptoms 2. Duration of effect as a counter irritant and relief of painful symptoms 3. Requirement of rescue medicines 4. Global assessment for overall relief in painful symptoms by the subject at the end of study. 5. Global assessment for overall effect by the investigator and Subject at the end of study 6. Comparative evaluation of onset of action, duration, intensity and sensorial parameters 7. Assessment of comparative safetyTimepoint: Day 7, Day 14, Day 21, Day 28	—

Measure

Time frame

1. Time of onset of action in relieving painful symptoms 2. Duration of effect as a counter irritant and relief of painful symptoms 3. Requirement of rescue medicines 4. Global assessment for overall relief in painful symptoms by the subject at the end of study. 5. Global assessment for overall effect by the investigator and Subject at the end of study 6. Comparative evaluation of onset of action, duration, intensity and sensorial parameters 7. Assessment of comparative safetyTimepoint: Day 7, Day 14, Day 21, Day 28

—

Countries

India

Contacts

Public ContactDr Sanjay Tamoli

Target Institute of Medical Education and Research

targetinstitute@yahoo.com9322522252

Outcome results

None listed

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