A clinical study to evaluate the efficacy of paste of Unani formulation with Paraffin wax therapy in the management of Non specific Low Back Pai

Phase 2

• Conditions: Health Condition 1: M959- Acquired deformity of musculoskeletal system, unspecifiedHealth Condition 2: M958- Other specified acquired deformities of musculoskeletal system

• Registration Number: CTRI/2024/08/072513
• Lead Sponsor: State Unani Medical College and Hospital, Himmatganj, Prayagraj)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Patients of low back pain as a primary complaint for more than 12 weeks.

2. No radiation of low back pain to other region.

3. Clinically and radiologically diagnosed

patients of Waja-uz-zahar (Non specific low back pain)

4. Patients who agreed to sign the informed consent and follow the protocol.

5. No allergy to Hulba, Katan, Roghan-e-babuna.

6. No apparent spine deformity like kyphosis, scoliosis, lordosis etc.

7. Willingness to participate in the study.

Exclusion Criteria

1. Patients below the age 18 years and above 50 years.

2. Any systemic illness such as Liver, Kidney, Cardiac disorders, Diabetes mellitus, Hypertension, Osteomylitis, Tuberculosis.

3. Spinal deformity (Congenital / Acquired), Paget’s disease, Pot’s spine, Spinal tumor and Cancer.

4. Previous history of Trauma, Fracture or Surgery of lumbosacral region.

5. Having evidence of infection on the skin over the lumbosacral region.

6. On contraceptive / Steroid and Analgesic therapy.

7. Patients who do not report for follow up and who refuses to join the study.

8. Pregnant women.

9. A systemic or local allergic reaction to Hulba, Katan, Kunjud and Babuna.

10. Impaired sensation.

11. Implantation of prosthesis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
? VAS (Visual Analogue Scale) <br/ ><br>? Oswestry low back pain disability questionnaire. <br/ ><br>Timepoint: 0, 7th, 14th, 21st and 28th day. <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
VAS (Visual Analogue Scale) <br/ ><br> <br/ ><br>Timepoint: 0 & 28th day.