Kunal Kamthe et al. / Journal of Pharmacy Research 2017,11(2),78-82
Kunal Kamthe1 , Omkar Kulkarni2
1 Prakruti Ayurveda Clinic, Pune, 2 Vedaratna Ayurveda and Panchakarma Clinic, Pune,Maharastra,India.
ABSTRACT Dengue, Chikungunya, Viral Fever and FUO are major threats for social health to India with many patients falling prey to such disorders in recent days. Several patients suffer from long term complications of these endemic fevers such as thrombocytopenia, weakness, joint pains, bleeding problems and occasionally death. Ayurveda, the traditional Indian science of medicine can offer effective solution to manage these endemic fevers. Cap PMA is an Ayurvedic formulation containing extracts of Tinospora cordifolia, Carica papaya and Swertia chirata processed in their juices targeted to increase platelet count affected by endemic fevers. A case series observational study was conducted at different private practitioners’ clinics in Pune, Maharashtra to evaluate the efficacy and safety of Cap PMA in endemic fevers. Total 37 adult patients (19 Males, 18 Females) were recruited using intention to treat model and treated with Cap PMA for 7 days. Primary objective was to assess effect of formulation on different clinical and hematological parameters and secondary objective was to assess tolerability of the formulation. The study revealed excellent tolerability of the formulation with no patient lost to follow up. The patients on treatment did not report any complications or adverse events during study period. All patients showed improvement in clinical and hematological parameters with significant increase in platelet count (p=0.0010, 95% Confidence interval). Other hematological parameters were not significantly affected by the disease as well as the formulation suggesting a protective role of the formulation in endemic fevers. The study reports a promising activity of Cap PMA in endemic fevers for restoration and increase in platelet count and preventing complications.
In recent times, several Endemic fevers like Dengue, Chikungunya, Typhoid etc. have evolved as the major threats for social health in India. Dengue infection (DI) has been the most important emerging viral diseases amongst them transmitted by mosquitoes to humans, in terms of both illness and death . Reappearance of dengue worldwide especially in the tropical and subtropical countries has turned this disease into a serious public health problem. Around 52% of the global population are at the risk of contracting Dengue fever (DF) or dengue hemorrhagic fever (DHF) lives in the South East Asian Region. DF is endemic in India for over two centuries as a benign and selflimited disease. However, in recent years, the disease has changed its course manifesting in the severe form as DHF, with increasing frequencies . Overpopulation, poor sanitary conditions, water logging has consequently led to increase in the incidence and prevalence of DF and DHF. All these endemic fevers, if not managed well,presents with a potential morbidity and mortality. Severe dengue and its complications, are a major cause of serious illness and death among children in some Asian and Latin American countries. Till date, there is no specific treatment than to conservatively manage the disease. But early detection and access to proper medical care has shown to lower rates of mortality below 1%. Chikungunya is a similar mosquito transmitted viral borne disease like dengue. Main symptoms presented are fever and severe joint pain with other symptoms like muscle pain, headache, nausea, fatigue and rash. Joint pain is often debilitating and can last for long time. The disease has some clinical signs like Dengue, and can be misdiagnosed in areas where dengue is common. There is also no cure for the disease and it is mainly focused on relieving the symptoms. Ayurveda, the traditional science of medicine has been one of the major healthcare provider for complicated and incurable diseases in India. A recent use of a variety of herbs and polyherbal formulations have shown good clinical benefit in patients with endemic fevers. However, their use in real life settings has not been studied at large. We have therefore designed the study to assess the effect of Cap PMA (A proprietary Ayurvedic formulation widely used for endemic fevers in Maharashtra) in real life setting.
2. MATERIALS AND METHODOLOGY
A prospective, multi center, intention to treat observational study has been conducted at various private practitioner’s clinics in Pune, Maharashtra. The patients suspected having viral fevers of any origin were prescribed with Cap PMA (1 capsule twice a day) for 7 days. They could take Tab Acetaminophen 350 mg as and when required for fever management. Routine blood biochemistry including Hemogram, ESR, Complete blood count, and Routine Urine were conducted before and after intervention. Clinical symptomatology was also noted as per patient reported gradations. A total of 37 adults(Age 18 – 65 years) patients were recruited for the study (19 Males and 18 Females) as per direct recruitment protocol.
2.1. Literature review In recent times, there have been several studies conducted to evaluate herbal drugs for the control of endemic fevers and especially for prevention of platelet degradation. Cap PMA contains Guduchi (Tinospora cordifolia), Erandakarkati (Carica papaya) and Kalamegha (Swertia chirata) in specified proportions processed in their respective juices for three times in the traditional Ayurvedic methods. After drying in shed capsules were prepared weighing 500 mg each (Table 1). Guduchi is one of the most important and widely used plants by Ayurvedic practitioners across the globe. It is commonly used for conditions like fever, joint pains, gouty arthritis, and skin disorders.
It is bitter in taste and has a hot potency as per Ayurvedic texts. It’s a celebrated plant for rejuvenation  and detoxifications. Modern researches have demonstrated a wide array of efficacy of Guduchi like anti-diabetic, digestive, hepatoprotective, anti-inflammatory, anticacer etc [8, 9]. Erandakarkati or commonly called Papaya leaves have strong antipyretic, antimicrobial activity. It is also shown to possess digestive stimulant properties. Its effect on dengue fever and specifically on platelets is well documented in the literature and has been demonstrated in latest case series and in vitro studies[10-12]. Kalamegha that is Swertia chirata is one of the most commonly used herb for all kinds of fever. It is bitter in taste and alleviates vitiated Pitta. It helps detox blood and has been proven to have hepatoprotective , anti-inflammatory  and antiviral .
3. RESULTS AND DISCUSSION
Platelets, also called thrombocytes (thromb – cyte, “blood clot cell”), are one of the important components in blood cytology whose function with the help of coagulation factors is to stop bleeding. They perform this by clumping and clotting blood vessel injuries. They are derived from the megakaryocytes of the bone marrow, and then enter the circulation. They also play important roles in several diverse processes beyond hemostasis and thrombosis, including promotion of inflammatory and immune responses, maintaining vascular integrity, and contributing to wound healing. They can store, produce and release pro-inflammatory, anti-inflammatory and angiogenic factors into the circulation and recruit leukocytes and progenitor cells to sites of vascular injury and thrombosis. Recent studies have demonstrated these functions to contribute in atherosclerosis, sepsis, hepatitis, vascular restenosis, acute lung injury, and transplant rejection. Decrease in their count is known as thrombocytopenia that occurs due to either decreased production or increased destruction as in the case of dengue or other viral fevers. The study was mainly focused on to assess the efficacy of Cap PMA in fevers with platelet destruction ability like Dengue, Chikungunya and Malaria. The medicine was used in the patients for 7 days and was selected on intention to treat basis. No patients were discontinued from the study because of progression of disease or any treatment related adverse events. This suggests a fairly good tolerability of the formulation in patients with endemic fevers. Pre-and post-hematological parameters were assessed from local laboratories under certified pathologist and reports were screened by blinded methods to avoid bias. The data was analysed using Microsoft Excel 365, Statistical Tools with using paired T test (95% Confidence interval). The summary of reports before and after the study are presented in (Table 2 and Figure 1-12.) Cap PMA showed significant improvement in the Neutrophils (Median 4700 before treatment – 5100 after treatment, p < 0.005), Platelet count (Median 122500 before treatment – 153500 after treatment, p < 0.005)suggesting efficacy in preventing platelet degeneration and improving platelet count in endemic fevers. Other blood parameters were also suggested no adverse effect if not improvement with the use of Cap PMA in endemic fevers. Guduchi and Kalmegha helps to reduce the fever and acts as immunity booster with the help of their qualities. Erandkarkati plays an important role in platelet count.
There was no any adverse effect of drug observed during the course of medication. Due to capsule form patients can easily take it without bitter taste. Hence no drop of any patient was observed.
The formulation, because presence of strong anti-viral, anti-pyretic and detoxification agents might have protected the degradation of platelets. It also suggests concomitant use of this formulation with standard medications in case of endemic fevers is well tolerable. A controlled placebo blinded studies however can be conducted to elucidate its safety and efficacy of this formulation in specifically prone dengue populations for prevention of platelet damage.
The authors would like sincerely thank all the physicians who participated and shared their data and experiences for the study.
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