Evaluation of the effectiveness of herbal anti-pain ointment to treat the types of musculoskeletal pains at different ages

Phase 2

• Conditions: L40.52; Condition 1: The types of musculoskeletal pains. Condition 2: Back pain. Condition 3: Rheumatoid arthritis. Condition 4: Sciatica. Condition 5: Neuro-Muscular pain. Condition 6: Arthritis. Condition 7: Psoriatic arthritis pain.; Diseases of the musculoskeletal system and connective tissue; Low back pain; Rheumatoid arthritis with rheumatoid factor; Sciatica; Neuromuscular scoliosis, lumbar region; Neurogenic arthritis, not elsewhere classified; Psoriatic arthritis mutilans; R29-8

• Registration Number: IRCT20211231053573N1
• Lead Sponsor: Vanda Noyan Oxin Teb Company

Brief Summary

This research aimed to fabricate a natural hybrid biomaterial and assess its physicochemical/biological properties to study the role of the therapeutic biomaterial in the growth of human monocytes, synoviocytes, chondrocytes, expression of type-I/II collagen, and osteogenic differentiation for bone tissue engineering applications, as well as to assess effects of bio-ointment derived from this biomaterial on relief of musculoskeletal pains. Hence, an oily formula [turmeric:ginger:chili pepper:rose oils (1:1:1:1w/w)] was mixed with the base oil [sesame:black seed:olive oils (1:0.4:0.6w/w)] in 3 wt ratios of 1:6(H1), 1.5:5.5(H2), and 2:5(H3). Accordingly, H2 indicated a better performance in cell growth and decrease of inflammatory mediators and led to the highest expression of osteoblastic genes of RUNX2, OCN, and OPN, as well as collagen I and II (COL1A1,COL2A) respectively 1.3-fold, 1.7-fold, and 1.4-fold, as well as %87 % and ~ 60 % higher than H1, and ~ 2-fold, 2.1-fold, and 3.4-fold, and ~ 19 % and ~ 16 % higher than H3. A clinical study on H2 was also performed on 50 patients with musculoskeletal pains. H2-based bio-ointment could relieve pain in less than 10 min for 40 % of patients and after 30 min from use for 35 %. Moreover, the analgesia period for 60 % and 36 % of patients lasted for longer than 3 h and between 2 h and 3 h, respectively. 76 % also stated that bio-ointment possesses stronger effects than other treatments along with moderate warming functions. Finally, although 6 % of patients reported mild effectiveness in pain relief, 92 % of users stated this therapeutic method has resulted in more effects on their pain relief and damaged organ performance recovery.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

All patients with the transient/acute/chronic musculoskeletal pains

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of skin sensitivity, speed and the level of effectiveness, as well as the potency of herbal anti-pain ointment to relieve/stop the pain. Timepoint: Evaluation of skin sensitivity (days 1, 3,7, and 14- Phase II); Evaluation of speed and the level of effectiveness, as well as the potency of herbal anti-pain ointment to relieve/stop the pain (the first 10 min, after 3 h, in weeks 1-6, in phase III). Method of measurement: Observe the skin to check for sensitivity/allergies. Questionnaire to assess the potency, speed, and the level of effectiveness of herbal anti-pain ointment to relieve/stop the pain.