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Clinical Researches Clinical Evaluation of Shilajatu Rasayana in patients with HIV Infection

AIDS is one of the serious global health concerns caused by Human Immuno Deficiency(HIV) virus and is predominantly a sexually transmitted disease. Currently there is no vaccine or cure for AIDS still Anti Retroviral Therapy (ART) is successful. It reduces both the mortality and the morbidity of HIV infection, but is expensive and inaccessible in many countries. However intense the therapy may be, HIV virus is rarely eliminated, and drug resistance is a major setback during long-term therapy. The development of new drugs and strategies and exploring alternative systems of medicine for antiviral herbs or drugs is the need of the age to improve treatment outcomes. Ayurveda describes many diseases which incorporate HIV like illness e.g. Rajayakshma, Ojo Kshaya, Sannipata jwara etc. HIV infection affects multisystems, chiefly the Immune System which can be correlated to Ojo Kshaya. Rasayana Chikitsa is the frontline therapy employed to treat Ojus disorders. Therefore Shilajatu ( Mineral pitch ), Centella asiatica (Mandukaparni), Tinospora cordifolia (Guduchi) and Emblica officinalis (Amalaki), well known for their Immuno-modulator and antioxidant properties were selected to evaluate their role on immune system. The study was carried on 20 patients from OPD and IPD of Kayachikitsa, S.S.Hospital, IMS, BHU and was randomly allocated into Treated group (Shilajatu +ART) and Control group (ART). Treated Group responded better to ART both clinically and biochemically. The results show that Shilajatu decreases the recurrent resistance of HIV virus to ART and improves the outcome of the therapy


Introduction
AIDS is one of the major global health concerns, highly infectious,and stands first as a sexually transmitted and incurable disease. AIDS is now a pandemic and globally, an estimate of 33 million people are affected with AIDS and AIDS has killed an estimate of 2.1 million people in 2007. Over three-quarters of these deaths occurred in sub-SAharan Africa, retarding economic growth and destroying human capital 1 .
AIDS is caused by Human Immuno Deficiency virus (HIV). HIV is a retrovirus that primarily targets CD 4+ helper T (a subset of T cells), cells that are responsible for the Immunity of an individual. Once HIV has killed so many CD 4+ T cells and there are fewer than 200 of these cells per microliter (µL) of blood, cellular immunity is lost and the person has said to be suffering from AIDS. This infection progressively reduces the effectiveness of the immune system and leaves individuals easily susceptible to opportunistic infections and tumors. HIV is transmitted through direct contact of a mucous membrane or the bloodstream with a bodily fluid containing HIV, such as blood, semen, vaginal fluid, seminal fluid, and breast milk. This transmission can involve anal, vaginal or oral sex, blood transfusion, contaminated hypodermic needles, exchange between mother and baby during pregnancy, childbirth, breastfeeding or other exposure to one of the above bodily fluids 2 .
As per (UNAIDS definition) 3 . ABC of AIDS prevention are: A-bstinence or delaying first sex. B-eing safer by being faithful to one partner or by reducing the number of sexual partners. C-orrect and consistent use of condoms for sexually active young people, couples in which one partner is HIV-positive 3 .
Currently there is no vaccine or cure for AIDS. Anti Retroviral Therapy (ART) is successful. It reduces both

Material & Methods
A total of 20 diagnosed cases of HIV infection receiving ART were selected from the OPD and IPD of Kayachikitsa, S.S.Hospital, IMS, BHU, after thorough examination and obtaining informed consent.

Inclusion criteria
• Newly diagnosed cases.
• Patient not having many complications or many secondary infections.
• CD 4 count not less than 150/ micro liter.
• Patients willing to participate and giving informed consent.

Exclusion criteria
• Patients below 20 yr. and above 40 yr. age group.
• Patients having multiple opportunistic infections and with complications like Diabetes, HTN, Asthma etc. • Pregnant and lactating women.

Diagnostic criteria
1. History taking like profession, having sex with many partners, blood transfusion etc. 2. Presence of clinical sign and symptoms suggestive of HIV.

Biochemical investigations like ELISA for HIV I/II
and CD 4 count.

Study Design
This was a randomized, controlled clinical trial conducted in Dept.of Kayachikitsa after obtaining permission from the Institutional Ethical Review Committee of IMS, BHU.
The 20 selected and diagnosed cases of of HIV infection were randomly allocated into two groups.The selected patients have undergone underwent complete general examination to rule out any gross abnormalities and were evaluated clinically and biochemically to confirm the diagnosis.

Grouping
Control Group (Gr-B) (N=8): Patients were given HAART Therapy from the AIDS clinic of Modern Medicine, S.S.Hospital, IMS, BHU.
Form of the trial drug: Capsules of 500mg each.

Route of Administration: Oral
Duration: 3 months.

Preparation of Shilajatu Rasayana
The trial drug was prepared in the the Dept.of Rasa Shastra, IMS, BHU. Shilajatu was first purified with Gomutra for 7 times and then powdered. The powder was triturated with Swarasa of Amalaki, Guduchi and Mandukaparni 7 times each, and packed into 500mg capsules and stored.

Discussion
Total 20 patients HIV cases with various symptoms were enrolled in the trial. On randomization, 12 were kept on ART+Shilajatu Rasayana (treated group) while 8 patients received only HAART therapy. Two patients in each group were dropped out as they discontinued the trial drug without the permission of the investigator. Confirmation of HIV was done only by ELISA for HIV I and II. The history taking showed that out of 20 registered cases, 18 were males with Vata-Pittaj prakriti, aged between 31-40 years, belonging to labour class (drivers and coolies) all married and majority with multiple sex partner history.
Shilajatu (Mineral pitch) is a herbo mineral compound with many beneficial therapeutic properties 8 . It has been extensively used by all the Ayurvedic scholars in all chronic debilitating disorders since decades. It has Kashaya Tikta rasas, Sheeta virya, TridoshAhara, Vrishya, Balya, Mutrala, Lekhana, Yogavahi and Rasayana properties 5 . It has many rich, bioactive molecules (nutrients, iron manganese, phenols etc)acts a powerful adaptogen in the wear and tear phenomenon of aging process 8 .
Amalaki is best among Vayasthpaka herbs. Amalaki, is fortified with Vit-C which is a natural, abundantly available powerful antioxidant, anti inflammatory and free radical scavenger of the metabolism 9 .
All the above drugs act as immune-boosters and adaptogenic, which act both on the body and the mind improve physical strength of the individual to fight against opportunistic infections and allergies and correct the mood disturbances in AIDS.
Drug was prepared in Department of Rasa Shastra, IMS, B.H.U. Shilajatu was triturated seven times with the swarasas (fresh juice extracts) of all the three herbs separately for 7 days each dried, powdered and then filled in 500mg capsules. It was administered as mentioned in the material and methods for 3 months. Response was assessed on the basis of improvement in signs and symptoms and CD 4 count. Safety profile of the drug was assessed by its impact on Liver enzymes and Urea, Creatinine which were evaluated before and after trial.
Symptoms and signs were graded as 0-3 depending on the severity. After completion of trial period, observations are shown in Table1.
Treated Group (HAART+Shilajatu Rasayana) showed 100% improvement in loss of appetite, nausea and vomiting and depression, 80% in diarrhoea and weight loss, 60% in fever, anaemia and cough, 50% in the oral thrush and sore throat. The control showed only 70% improvement in anemia, fever, diarrhoea and weight loss; 50% improvement in loss of appetite, nausea, cough and depression.
Objective improvement was assessed by the increase in CD 4 count.Both groups responded more or less similarly but the control group showed rising values of SGOT, SGPT, Alkaline Phosphatase, Urea and Creatinine. The HAART is associated with hepatic and kidney decompensation which was successfully overcome by giving Shilajatu rasayana. Shilajatu, Amalaki and Guduchi by virtue of its properties enhances the immunity by increasing CD 4 T helper cell counts, prevents the resistance of HIV virus to ART drugs. It also enhances the excretion of Virus load from the body but needs to be substantiated by the data. AIDS has social stigma and individuals with AIDS are socially boycotted and subjected to frequent insult, which makes their lives lead burdensome and frustrated. Mandukaparni is a Medhya herb with tranquilizing properties successfully improved the overall outcome of the trial drug.
Shilajatu has many rich, bioactive molecules (nutrients, iron manganese, phenols etc) acts a powerful adaptogen in the wear and tear phenomenon of aging process. Shilajatu Rasayana on triturating with Amalaki, is fortified with Vit-C which is a powerful antioxidant, Guduchi (Giloy) a bitter active principle has anti-inflammatory and hepato-protective properties.It acts on liver, the chief site of metabolism of food and drugs, improving its functions. ART is chiefly associated with alteration in Liver Function Tests, these were reversed and normalized by Guduchi. Mandukaparni fresh leaf extract has memory enhancing and tranquilising properties which treat the depression often associated with HIV patients.

Conclusion
The compound formulation was found to be safe, (on prolonged use for 3 months in the dose of 6 gm ) and it has decreased the intensity of the clinical symptoms and signs and also protected the liver from the hepatotoxicity of ART as evident by normal LFT or Kidney function tests.