Original Research Article
Year: 2019 | Month: September | Volume: 6 | Issue: 9 | Pages: 87-96
Efficacy of Unani Formulations in Waja-ul-Khasirah (Low Back Pain) – A Randomised Double Dummy Clinical Trial
Siddiqui Aafreen1, M.A. Siddiqui2, M.A. Quamri3, Barkati Md. Tarique4, Khan Saba5
1 Lecturer, 2Professor, 3Reader, Dept. of Moalajat (Medicine), National Institute of Unani Medicine, Bengaluru, Karnataka, India-560091
4 Medical Officer (Unani), Dept. of AYUSH, AIIMS Bhopal, Madhya Pradesh, India-462020
5 Lecturer, Dept. of IQAN, Markaz Unani Medical College & Hospital, Kozhikode, Kerala, India-673586
Corresponding Author: Siddiqui Aafreen
ABSTRACT
Background and Objectives: Low Back Pain (LBP) is an essentially ubiquitous phenomenon. It is the major cause of disability and work absenteeism throughout the world with an enormous impact on individuals, families and communities. Aim of this study was to compare the efficacy of non-pharmacopoeial oral Unani formulation and Roghane Suranjan in Waja-ul-Khasirah (LBP) with an objective of relief in LBP and improvement in quality of life (QoL).
Methods: This randomised single blind double dummy placebo controlled clinical trial was carried out at NIUM Hospital, Bengaluru on 42 patients of either sex, between the age of 18-55 years, with specific LBP, back stiffness and difficulty in movements by randomly allocated them to group A {non-pharmacopoeial oral Unani formulation (test drug) + placebo oil, n=21} and group B {Placebo oral + Roghane Suranjan (test drug), n=21}. Both groups were treated with oral formulation (03 capsules of 800mg thrice a day) and oil (15ml for local application on Lumbo-sacral region daily twice a day) for 21 days with three weekly and one post treatment follow up to see the residual effect of drug. The effect of study was assessed with improvements in primary outcome such as LBP (VAS grades), Stiffness in the back and Difficulty in movements (arbitrary scale) and secondary outcome with improvement in QoL (ODI and QBPDS scores). The data was analysed by using Fisher’s exact, Chi-square, Friedman, Kruskal-Wallis, Repeated measures and one way ANOVA with Tukey post hoc multiple comparison test for both intergroup and intragroup comparisons.
Results: Inter and Intragroup analysis shows statistically significant improvements in LBP, back stiffness, difficulty in movements and in QoL (p<0.001) whereas, residual effect of drugs was found insignificant (p>0.05). Both groups were found safe without any adverse effect.
Interpretation and Conclusion: The study outcome suggests that both groups were effective and safe clinically and statistically in Waja-ul-Khasirah (Low Back Pain) and the non-pharmacopoeial oral Unani formulation (Group A) was found superior in comparison of Roghane Suranjan (group B).
Key words: LBP; double dummy; ODI; QBPDS; Unani; Roghane Suranjan
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