A Comparative clinical study of Gomutra Haritaki with and without Langhana and Pachana in the management of Dyslipidemia.

The present study is randomized parallel, double arm clinical study to compare effect of Gomutra Haritaki with and without Langhana and Pachana. Gomutra Haritaki described in Ashtanga Hridaya Samhita Chikitsa Sthana 8/55, consists of Haritaki (Terminalia chebula retz.) and Gomutra (cow urine). For the preparation of Gomutra Haritaki, Haritaki(1 part) was boiled until Gomutra (2.5 part) evaporated and the granules of semisolid consistency were punched into tablets of 500 mg each. Total 153 patients were registered for the present clinical trial. In Group A, 76 patients were registered, out of them 70 patients completed the treatment while in Group B, 77 patients were registered and out of them 68 patients completed the treatment. Group A, Langhana and Pachana followed by Gomutra Haritaki For the purpose of Langhana (light diet) i.e., one time regular meal (lunch) and Mudga Yusha(green gram soup) in dinner for 4 days was advised. This was followed by Pachana for 10 days with Dhanyaka-Shunthi Sidhha Jala. Dhanyaka-Shunthi Sidhha Jala was prepared by mixing of 400 ml of water with 6 gm drug [ 4.5 gm Dhanyaka (coriandrum sativum Linn.) and 1.5 gm Shunthi (zingiber officinale Rosc.) ] was boiled until 200 ml water was evaporated. This medicated water was given for twice a day at morning and evening 6 pm. After 10 days of Pachana, Gomutra Haritaki was administered in the dose of 500 mg each, 2 tablets with luke warm water (Ushnodaka) before food thrice a day for 8 weeks. Group B, Placebo capsules followed by Gomutra Haritaki For initial 14 days, 2 capsules (starch powder) of 500 mg each twice daily were given to compare the effect of placebo with Langhana and Pachana. During this period no diet restriction was done. Followed by placebo capsules,  Gomutra Haritaki was administered 2 tablets 500 mg each with luke warm water before food thrice a day for 8 weeks. Patients were assessed before treatment, after 14 days Langhana-Pachana or placebo treatment and after treatment, bio chemical parameters-lipid profile were also done during this interval. Results: After 14 days of course with  Langhana and  Pachana in Group A, S. Cholesterol (7.66%), S. Triglyceride (13.56%), S.LDL (7.89%), S.VLDL (15.39%) were decreased which were statistically significant. S.HDL was decreased by 3.36% which was statistically insignificant. In Group B where only placebo treatment was given without diet restriction. S.Cholesterol (0.51%), S. Triglyceride (2.20%), S.VLDL (3.24%), S.HDL (1.15%) were increased which were statistically insignificant. S.LDL was decreased by 0.01% which was statistically insignificant. Over all effect of therapy which was calculated by difference at baseline and after administration of Gomutra Haritaki  showed that in Group A, S. Cholesterol (8.59%), S.Triglyceride (8.72%), S.LDL(11.45%), S.VLDL (10.76%) were decreased which were statistically significant. S.HDL was decreased by 2.11% which was statistically insignificant where in Group B, S.Cholesterol (9.51%), S. Triglyceride (7.91%), S.LDL (13.14%), S.VLDL (7.63%) were decreased which were also statistically significant. S.HDL was decreased by 2.5% which was statistically insignificant. After applying unpaired t test for comparison of overall effect of Group A and B, it was found that difference of results reported in their Groups on S.Cholesterol, S.Triglyceride, S.LDL, S.VLDL, S.HDL were statistically insignificant. In Group A, lipid profile was decreased significantly after Langhana and Pachana of 14 days and almost remained stable after administration of Gomutra Haritaki while in Group B no change was observed after placebo for 14 days but lipid profile was significantly reduced after administration of Gomutra Haritaki.