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Articles by Madani SH
Total Records ( 5 ) for Madani SH
  Abdollahi M , Farzamfar B , Salari P , Khorram Khorshid HR , Larijani B , Farhadi M and Madani SH
  Semelil (ANGIPARS™), an herbal formulation containing Melilotus officinalis extract, is a novel compound being developed for treatment of chronic wounds, particularly diabetic foot ulcers. The purpose of this study was to investigate toxicological, pharmacological, and pathomorphological effects of I.M. and I.P. administration of Semelil in animals.
The acute toxicity parameters of Semelil diluted in normal saline (1:10 or 1:5) were determined after a single injection into BALB/c mice and Wistar rats in two steps. First, the LD50 was approximately assessed and then the precise lethal dose indices were estimated by the probit-analysis method. Specific single-dose effects of Semelil were monitored for clinical signs of toxicity, including general state of the animals, changes in their behavior, hematological and biochemical parameters for 14 days after drug administration. Then, subacute-chronic toxicity was evaluated in rats treated with Semelil for 3 months.
In acute toxicity study, the calculated LD50 for drug diluted at 1:5 was in the range of 44-52 ml/kg. The adverse effects at drug doses close to the LD50 included depressed mood, narcosis, and sleep. No adverse pharmacological or toxicological effects of the drug diluted at 1:10 and administered in the single-dose (25-50 ml/kg body wt.) or chronically (daily doses of 0.07 and 0.21 ml/kg body wt.) were noted. Thus, the animal studies demonstrated a favorable safety profile for the phytotherapeutic Semelil.
  Khorram Khorshid HR , Sadeghi B , Heshmat R , Abdollahi M , Salari P , Farzamfar B and Madani SH
  Semelil is a novel herbal-based compound formulated for treatment of bed sore and diabetic foot ulcer. The objective of the present preclinical study was to assess the mutagenicity and genotoxicity of Semelil in full compliance with the standard guidelines for testing chemicals.
The potential genotoxicity of Semelil, as part of the safety evaluation process was assessed in three different in vitro and in vivo tests, including bacterial reverse mutation (Ames test), mammalian bone marrow chromosomal aberration, and rodent dominant lethal assays.
Effects of Semelil was clearly negative at different doses in the Ames test. No statistically significant differences were observed between the levels of chromosomal aberrations in bone marrow cells of mice from the experimental and control groups. The rate of post-implantation losses and thus, the number of lethal mutations in germ cells at different stages of spermatogenesis in male mice treated with a single dose of Semelil did not statistically exceed the control rate. While on the basis of these observations, Semelil can be considered genotoxically safe, further investigations using other bio-assays for mutagenicity studies are warranted.
  Larijani B , Heshmat R , Bahrami A , Delshad H , Ranjbar Omrani G , Mohammad K , Heidarpour R , Mohajeri Tehrani MR , Kamali K , Farhadi M , Gharibdoust F and Madani SH
  Some diabetic foot ulcers, which are notoriously difficult to cure, are one of the most common health problems in diabetic patients .There are several surgical and medical options which already have been introduced for treatment of diabetic foot ulcers, so some patient will require amputation. The purpose of this study was to evaluate the efficacy of intravenous Semelil (ANGIPARS™), a naive herbal extract to accelerate healing of diabetic foot ulcers. A multi-centric randomized controlled trial was conducted to evaluate intravenous Semelil for healing of diabetic foot ulcers. Sixteen diabetic patients were treated with intravenous Semelil, and nine other patients were treated with placebo as control group. Both groups were otherwise treated by wound debridement and irrigation with normal saline solution, systemic antibiotic therapy and daily wound dressing. Before and after intervention, the foot ulcer surface area was measured, by digital photography, mapping and planimetry. After 4 weeks, the mean foot ulcer surface area decreased from 479.93±379.75 mm2 to 198.93±143.75 mm2 in the intervention group (p = 0.000) and from 766.22±960.50 mm2 to 689.11±846.74 mm2 in the control group (p = 0.076). Average wound closure in the treatment group was significantly greater than placebo group (64% vs. 25%, p= 0.015). This herbal extract by intravenous rout in combination with conventional therapy is more effective than conventional therapy by itself probably without side effect. However, further studies are required in the future to confirm these results in larger population.
  Bahrami A , Kamali K , Ali-Asgharzadeh A , Hosseini P , Heshmat R , Khorram Khorshid HR , Gharibdoust F , Madani SH and Larijani B
  ANGIPARS™ is a new herbal extract which has been produced in oral, topical, and intravenous forms. The present article contains preliminary results of the study which was planned to evaluate the efficacy and safety of orally applied ANGIPARS™ and to compare it with the combination of oral and topical forms and also with conventional therapy in patients with diabetic ulcers of the lower extremities.
Twenty one patients with diabetic foot ulcers were divided into 3 groups. The first group received 100 mg of oral ANGIPARS™ twice a day for 6 weeks in addition to conventional therapies. In the second group, ANGIPARS™ gel 3% was added to the oral form of the same product besides the conventional therapies for the same period of time. Finally, in the third group which was considered as control, only conventional therapies were performed. The patients were followed for 6 weeks. Parameters such as granulation tissue formation, skin epithelization, and wound surface areas changes were analyzed to determine the effectiveness of the compound in wounds healing. Furthermore, drug safety was assessed by monitoring adverse events and by clinical and laboratory evaluations.
The study data showed significant differences between the intervention and control groups with respect to efficacy and tolerability. In each intervention group, primary wound healings occurred following 2 weeks. Complete wound healing which was greater than 70% improvement in wounds surface areas was achieved in 83% and 100% of group 1 and group 2 participants, respectively after 6 weeks. On the other hand, at the same period of time, only 22.2% of patients in control group revealed complete healing. Therefore, ANGIPARS™ had significant positive effect in increasing the incidence of complete wound closure compared with control group (p = 0.042). However, our evaluations indicated that adding topical treatment with 3% gel once a day to the oral therapy with the same product did not make significant difference in healing outcomes statistically (p = 0.769). Clinical and paraclinical evaluations did not show any adverse events during the study.
This study showed that in diabetic foot ulcers, either treatment with oral ANGIPARS™ capsules (100mg) twice a day or combination therapy with oral and topical forms, in conjunction with good wound care significantly increased the incidence of complete wound closure. In addition, the application of this product was safe and did not make any unexpected adverse event.
  Shamimi Nouri K , Karimian R , Nasli E , Kamali K , Chaman R , Farhadi M , Madani SH , Larijani B and Khorram Khorshid HR
  Pressure ulcers are one of the major health care problems and results in a substantial amount of burden for both patients and health services. The aim of this study was to appraise effectiveness of topical Semelil (ANGIPARS™), a naive herbal extract, in pressure ulcers
As a randomized controlled clinical trial, 18 patients with pressure ulcers were recruited from Vali-e-Asr hospital, Medical Sciences/ University of Tehran, Iran. Nine patients received topical Semelil (ANGIPARS™) during hospitalization and nine other patients received conventional treatment.
Baseline characteristics of the topical and control groups did not differ across demographic, clinical and functional measures. The mean surface areas of the ulcers were reduced 48.2 ± 85.3 cm2 (78.3%) and 2.8± 6.2 cm2 (6.3%) in the treatment and control groups, respectively (p=0.000).
From the results of this study it may be concluded that the use of topical Semelil (ANGIPARS™) with conventional treatment is more effective than those of only conventional treatment for patients with pressure ulcers.
 
 
 
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