Efficacy of Unani polyherbal formulation as an adjunct therapy in category-I tuberculosis patients on DOTS therapy

Tuberculosis (TB) is a specific infectious disease caused by Mycobacterium tuberculosis. The disease primarily affects the lungs and causes Pulmonary Tuberculosis. It is one of the world’s major communicable infectious diseases, and it still imposes a great health burden in developing countries. It is one of the leading causes of mortality worldwide. According to World Health Organization (WHO), 10.4 million TB patients were reported in 2016, with annual death of 1.7 million. Of global total, India had 26% of reported TB death in the same year. Today it ranks as the second leading cause of death from an infectious disease worldwide, after the human immunodeficiency virus. An estimated one third of the world population has been infected. India remains the highest TB burden country giving an estimated incidence of 2.2 million cases out of a global incidence of 9.6 million cases.

The predominant symptoms of active TB are fever, night sweat, weight loss and chronic cough with blood containing sputum. Most of the people do not show signs of TB disease (termed latent infection). However, most TB infections which are latent may progress into active disease if left untreated.

Treatment of TB using Directly Observed Treatment Short – course (DOTS) therapy comprises multiple antibiotics is quite lengthy and causes serious side-effects in different organs.  The length of the TB treatment leads to withdrawal from the patients, which paves the way for the emergence of drug resistance in bacterial population. Due to the side effects of the drugs, poor medication compliance and the problem of development of drug -resistant TB, global investment in TB research is needed. Among the first-line anti-Tb drugs, side effects of hepatotoxicity have been reported to be associated with isoniazid, rifampicin and pyrazinamide; cutaneous reactions with isoniazid, pyrazinamide and ethambutol. Long-term respiratory symptoms and impairment of pulmonary function affect patients’ quality of life.

The key objective is to discover and develop new drugs that can improve treatment strategy, enhance safety and address both infection and side effects. These concerns related to therapy need serious and immediate interventions. In absence of effective therapeutic drugs for TB, hope is built on plant based natural products due to their chemical diversity and important role as phyto-drugs.

In ancient Unani literature, the physicians termed Tuberculosis as Diq and Sil and described TB under both headings separately. Sil being emaciation and Diq means low- grade fever which is one of the cardinal symptoms of the disease.

Unani physician, Abu Bakr Mohammed Bin Zakriya Razi (Rhazes) has mentioned a formulation in his book Kitab al Hawi for intense fever and roughness of lungs in Tuberculosis. The following drugs: Banafsha, Aslasoos, Maweez munnaqa, Sapistan, Unnab, Khiyar shambar and turanjabeen are given in the form of Joshanda(decoction).  Recent studies showed that these drugs have properties like antioxidant, immunomodulator, anti-tubercular, hepatoprotective and anti-inflammatory. These drugs are easily available and cost effective. Hence,this study is intended to evaluate the effect of Unani polyherbal formulation as an adjunct therapy in newly diagnosed Pulmonary Tuberculosis patients.