The emphasis of research work is mainly to develop newer surgical techniques and development of formulations for treatment of various diseases for which there are limitations in the modern system of medicine. Medical management of urinary calculus and wound healing is the challenging task for modern medicine. In the traditional system of medicine number of herbs or formulations derived from them are prescribed to treat these conditions. However, such formulations are not acceptable at a global level, mainly due to the lack of standardization protocol to validate uniformity and consistency. There are a number of publications on the preclinical aspect of such formulations; however, these leads are not validated further for clinical use or application. In addition, on such formulations derived from natural products hardly systematic prospective clinical studies have been carried out to understand safety, efficacy, exact indication and limitations of the treatment following GCP norms. Under this scenario during the last decade, it was decided to undertake research projects based on traditional Ayurvedic knowledge, employing natural products for the development of formulations for the treatment of Kidney stone and wound healing at the ACE hospital research centre.
Based on infrastructure and research achievements in this institution, Scientific Industrial Research Organization (SIRO) status was awarded by the Department of Science and Technology (DST), Government of India.
To conduct the clinical research as per global and national norms, Institutional Ethics Committee (IEC) was constituted and is registered with the Central Drugs Standard Control Organization, New Delhi (CDSCO).
The institution is recognized by Maharashtra University of Health Sciences (MUHS), Nasik, for Postgraduate studies in Urology.
The financial support was awarded for the research project on ‘Herbmed’- a herbal formulation for the treatment of Urolithiasis by Department of Science and Technology, Government of India.
Drug development and clinical research is a multidisciplinary activity and inputs from various scientific disciplines are essential. In order to increase the scope of research work, the collaborations with national and international Laboratories viz.
- Indian Institute of Technology, (IIT) Mumbai
- Indian Drugs Research Association and Laboratory, Pune.
- University of Pune
A Clinical trial is a core activity of the research department. In view of this number of clinical trials were completed in the past and some are ongoing. We are conducting In house clinical trials as well as Sponsor trials by various renowned National & International pharmaceutical companies. All these trials are conducted after approval of IEC and registration with CTRI as per standard norms.
- In-house Trials
|A phase II, 28 weeks, Randomized, Double-blind, Placebo-control, Parallel-group Study to Evaluate Safety and Efficacy of ” Herbmed plus” an Ayurvedic formulation in the patient with Renal calculi.||Completed|
|A double-blind exploratory three-arm randomized trial to evaluate the Safety and Efficacy of Herbal preparation ‘Herbmed plus’ in urethral stent discomfort.||Completed|
|An exploratory trial of Herbmed plus for patients with recurrent stone||Completed|
- Sponsored Trials
|Sr.no||Title of project||Sponsor|
|1.||“Efficacy and Tolerability of Intravenous Administration of Ceftazidime + Clavulanic acid in Complicated Urinary Tract Infection and Pyelonephritis”||Ranbaxy Pvt.Ltd, Bombay|
|2.||A multicentre clinical trial of male Sexual Health under the protocol: ID: VL/080305/DM titled “Double-blind placebo-controlled, randomized study to evaluate the safety and efficacy of Vig Rx Plus capsules as dietary supplements to improve erectile function and maintain Male Sexual Health.”||Vedic Life Sciences Pvt, Ltd, Bombay|
|3.||Efficacy, safety and Tolerability of Urovaxom in Reduction of UTI Episodes in Recurrent Lower Urinary Tract Infection ( Ruti) -a randomized, double-blind, placebo-controlled parallel group study||Ranbaxy Pvt.Ltd, Bombay|
|4.||An open-label Randomized, parallel group, prospective, Multicenter clinical trial for evaluation of efficacy and safety of In -ALRN-001 in comparison with Tamsulosin in patients with lower urinary tract symptoms associated with BPH||Intas Pharmaceuticals Limited, Ahmadabad|
|5.||Safety and tolerability and Efficacy of Injection SUDOPEN in the Treatment of Moderate to severe infections||Ranbaxy Pvt.Ltd, Bombay|
|6.||Clinical Study to Evaluate the Efficacy and Tolerability of Ferric Carboxymaltose Injection||Emcure Pharma, Pune|
|7.||‘A randomized, multicenter, phase-III study to test the therapeutic equivalence, safety and pharmacokinetics of a new monthly depot formulation (3.75 mg/month) of leuprolide acetate (Leuprolide Sun 3.75 mg) versus Lucrin in subjects with locally advanced and metastatic prostate cancer,’ Version 01 dated 13 Oct 2011, Sponsor by Sun Pharmaceutical Industries Ltd, Mumbai.||Sun Pharmaceutical Industries Ltd, Mumbai|
|8.||An Open-label, Randomized, Parallel-group prospective multicenter clinical trial for evaluation of efficacy and safety of In ALRN-002 IN comparison with Naftopidil in Patients with Lower Urinary Tract Symptoms associated with BPH||Intas Pharmaceuticals Limited, Ahmadabad|
|9.||A double-blind, randomized, comparator-controlled study to assess the safety and efficacy, and Pharmacokinetics of ACHN -490 Injection administered Intravenously (IV) in patients with complicated urinary tract infections (c UTI) or acute pyelonephritis (AP)||Achaogen Inc, Haryana|
|10.||Rehabilitation approach by yoga-based exercise in End Stage Renal Failure (ESRF) patients on Hemodialysis: A randomized controlled study||Project for the submission to Department of AYUSH Government of India for funding|
|11.||Comparative Efficacy, Safety and Tolerability of Inj. Cefozopran Hydrochloride and Inj. Cefpirome Sulphate in the treatment of Complicated Urinary Tract Infections and Pyelonephritis- An Open-Label Study (Study Number R2011004)||Ranbaxy Pvt.Ltd, Bombay|
|12.||“A Double-blind, Placebo-controlled Study to Evaluate New or Worsening Lens Opacifications in Subjects with Non-metastatic Prostate Cancer Receiving Denosumab for Bone Loss due to Androgen-Deprivation Therapy.” Study Number: 20080560||Amgen Technology Pvt Ltd, Mumbai|
|13.||A randomized, open-label, multi-centre study to evaluate the efficacy, tolerability and safety of darbepoetin alfa compared to erythropoietin in anaemia associated with chronic kidney disease(CKD)||Hetero Drugs Ltd, Hyderabad|
Publications: The research work carried out under various projects like developing new surgical techniques and drug development are being published in SCI journals of repute. So far 18 research papers were published in a renowned journal like:
- Journal of Gynecologic Surgery
- International Journal Endourology
- Journal of Endourology
- International Journal of Urology
- Journal of Alternative and Complementary Medicine
- Journal of Laproendoscopic and Advanced Surgical Techniques
- Journal of Minimal Access Surgery
- International Journal of Pharmacy and Pharmaceutical
- BMC Complementary and Alternative Medicine
Presentations: The research work carried out under various projects is being presented at National & International Conferences, Seminars, etc. Some of them are
- American Urological Association Conference, Orlando, USA, on May 14-21 2014
- 31st Congress of the Societe Internationale d’Urologie (SIU), Berlin, Germany, on October 16-20 2011
- The Indian patent No. 249299 on 17/10/2011 for “A synergistic herbal formulation for the treatment of renal condition” was awarded for the formulation Herbmed.
- The US patent No. 8,709,509 dated 29th April 2014 for “Novel Herbal Composition for the treatment of Wound Healing” was granted to Anuradha oil.
- The Indian, International, US and European patent applications for Herbmed plus and European patent for Anuradha oil are under consideration.