List of Indian Clinical trials which have been completed and published

TOTAL NO OF TRIALS: 18

TOTAL NO OF PUBLICATIONS: 34

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MALE INFERTILITY
CA PROSTATE- Advanced Ca Prostate
CA PROSTATE - Hormone Refractory Ca Prostate
CA PROSTATE - High Grade Prostate Intraepithelial Neoplasia
BRAIN TUMORS
PRE-CANCEROUS ORAL LESIONS - Oral Leukoplakia
PRE-CANCEROUS ORAL LESIONS - Oral Submucous Fibrosis
PRE-CANCEROUS ORAL LESIONS - Oral Lichen Planus
ORAL HEALTH – Gingivitis
OBS AND GYNAE - Preeclampsia & IUGR OBS AND GYNAE - Menopausal complications
CARDIOVASCULAR DISORDERS
TYPE 2 DIABETES
CATARACT

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TRIAL 1:

Investigator:
Dr. NK Mohanty, Head of Dept. (Urology), VM Medical College
& associated Safdarjung Hospital, New Delhi.

TRIAL 2:

Investigator:
Prof. NP Gupta, Head of Dept. (Urology), AIIMS, New Delhi.

Publications:
•  Lycopene therapy in idiopathic male infertility - results of a clinical trial. Kumar R, Gupta NP. IJU 2001 :16, 27-28 Read more.

•  Management of idiopathic oligoasthenospermia with lycopene. Mohanty NK, Kumar S, Jha AK, Arora RP. IJU 2001 :18(1): 57-61 Read more.

•  Lycopene therapy in idiopathic male infertility - a preliminary report. Gupta NP, Ansari MS. Int Urol Nephrol. 2002: 4(3): 369-72. Read more.

•  Emerging role of lycopene in male infertility. Gupta NP . 1 st Int Conf on health benefits of Lycopene 2003, USA
Read more.

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TRIAL 3:

Investigators:
Prof. NP Gupta, Head of Dept.(Urology), AIIMS, New Delhi, INDIA

Publications:
•  Chemoprevention of carcinoma prostate: a review. Ansari MS, Gupta NP, Hemal AK. Int Urol Nephrol. 2002 ; 34(2): 207-14. Read more.

•  A comparison of lycopene and orchidectomy vs orchidectomy alone in the management of advanced prostate cancer. Ansari MS, Gupta NP. BJU Int. 2003 ; 92: 375-378. Read more.

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TRIAL 4:

Investigator:
Prof. NP Gupta, Head of Dept.(Urology), AIIMS, New Delhi , INDIA

Publication:
•  Lycopene: A novel drug therapy in hormone refractory metastatic prostate cancer. Ansari MS, Gupta NP. Urol Oncol. 2004 ; 22(5): 415-20 Read more.

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TRIAL 5:

Investigator:
Dr. NK Mohanty, Head of Dept.(Urology), Safdarjung Hospital, New Delhi , INDIA

Publications:
•  Role of lycopene as chemopreventive in treatment of high-grade intraepithelial neoplasia (HGPIN) Mohanty NK, Nayak R, Arora R and Malhotra V . BJU Int (S 2) 2004 (94): 92-93 Read more.

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BRAIN TUMORS

TRIAL 6:

Investigator:
Dr. PK Julka, Dept of Radiation Oncology, AIIMS, New Delhi , INDIA

Publication:
Role of natural lycopene and phytonutrients along with radiotherapy and chemotherapy in high grade gliomas . Puri T, Julka PK, Goyal S, Nair O, Sharma DN, Rath GK. Journal of Clinical Oncology, 2005 ASCO Annual Meeting Proceedings . 23(16S): 1561. Read more.

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PRE-CANCEROUS ORAL LESIONS
- Oral Leukoplakia

TRIAL 7:

Investigator:
Dr. Mohit Pal Singh, Dept of Oral Medicine and Radiology, K.L.E.S's Institute of Dental Sciences, Belgaum, INDIA

Publications:
•  Efficacy of oral Lycopene in the treatment of oral leukoplakia. Singh MP, Krishannappa R, Bagewadi A, Keluskar V. Oral Oncology 2004, 40: 591-596 Read more.

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TRIAL 8:

Investigator:
Dr. Abhinav Kumar, Dept of Oral Medicine and Radiology, K.L.E.S's Institute of Dental Sciences, Belgaum, INDIA

Publication:
Efficacy of Oral Lycopene in Oral Submucous Fibrosis. Kumar A, Bagewadi A, Keluskar V, Singh MP. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2007, 103(2): 207-13 Read more

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PRE-CANCEROUS ORAL LESIONS
- Oral Lichen Planus

TRIAL 18:

Investigator:
Dr. Nisheeth Anshumalee, Dept of Oral Medicine and Radiology, College of Dental Science, Davangere, Karnataka, INDIA

Publication:
Oxidative Stress and Oral Lichen Planus: A Possible Association? Anshumalee N, Shashikanth MC, Sharma S. The Cusp 2007, 4(2): 31-4 Read more

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TRIAL 9:

Investigator:
, Dr. Rampalli Viswa Chandra, Department of Periodontics Krishnadevaraya College of Dental Sciences, Bangalore, INDIA

Publication:
Efficacy of Lycopene in the treatment of Gingivitis: a randomized, placebo-controlled clinical trial.Chandra RV, Prabhuji MLV, Roopa AD, Ravirajan S, Kishore HC. Oral Health Prev Dent 2007 ; 5: 327-336. Read more.

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TRIAL 10:

Investigator:
Dr. JB Sharma & Dr. Ashok Kumar, Dept of Obs & Gyn, Maulana Azad Medical College & associated LNJP hospitals, New Delhi, INDIA

Publications:
•  Effect of lycopene on pre-eclampsia and intra-uterine growth retardation in primigravidas. Sharma JB, Kumar A, Kumar A, Malhotra M, Arora R, Prasad S, Batra S. Int J Gyn Obs, 2003 ; 81(3): 257-62 Read more.

•  Oxidative stress & Preeclampsia. Sharma JB, Mittal S, Editorial; Obs & Gynae 2004: 10(9) Read more.

•  Lower antioxidant levels may explain both preeclampsia and cancers. Sharma JB, Mittal S. BMJ.com Rapid responses for Paltiel et al., 2004; 328(7445): 919-0. Read more.

Awards:
•  IJGO prize paper 2003 for best paper from a developing country in the year 2003 Read more.

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TRIAL 11:

Investigator:
Dr. JB Sharma, Dr. Sunita Mittal, Dr. Deepika Deka & Dr. A. Sharma, Dept of Obs & Gyn & Dept of Biochemistry, AIIMS, New Delhi, INDIA

Publications:
Oxidative stress markers and antioxidant levels in normal pregnancy and pre-eclampsia. Sharma JB, Sharma A, Bhadur A, Vimala N, Satyam A, Mittal S. Int J Gynaecol Obstet. 2006 ; 94(1): 23-7  Read more.

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OBS AND GYNAE
- Menopausal complications

TRIAL 12:

Investigator:
Dr. Renu Misra, Dept of Obs & Gyn, AIIMS, New Delhi, INDIA

Publications:
•  AIIMS research finds fountain of youth in the humble tomato. Mishra R, Mittal S. Indian Express, March 20, 2004 ExpressNews

• LycoRed as an alternative to hormone replacement therapy in lowering serum lipids and oxidative stress markers: A randomized controlled clinical trial. Misra R, Mangi S, Joshi S, Mittal S, Gupta SK, Pandey RM. J Obs Gyn Res 2006; 32(3): 299-304.  Read more.

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TRIAL 13:

Investigator:
Dr. NC Krishnamani, Dept of Cardiology, Ram Manohar Lohia Hospital, New Delhi, INDIA  Read more.

TRIAL 14:

Investigator:
Dr. SK Gupta , Head of Dept. (Pharmacology), AIIMS, New Delhi, INDIA

Publications:
•  Correlation of Plasma Lycopene Levels with Obstructive Coronary Artery Disease . Krishanmani NC. IHJ 2004, 56, 381 Read more.

•  Cardioprotective effect of lycopene in the experimental model of myocardial ischemia-reperfusion injury. Bansal P, Gupta SK, Ojha SK, Nandave M, Mittal R, Kumari S, Arya DS. Mol Cell Biochem. 2006, 289(1-2):1-9 Read more.

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TRIAL 15:

Investigator:
Investigators: Dr. S.K.Agarwal (Head-Medicine Dept.) and Dr. Sunandan Sikdar, Dept of Medicine, Maulana Azad Medical College & associated LNJP hospitals, New Delhi, INDIA

TRIAL 16:

Investigator:
Investigators: Dr. S.K.Agarwal (Head-Medicine Dept.) and Dr. Avinash Gahlot, Dept of Medicine, Maulana Azad Medical College & associated LNJP hospitals, New Delhi, INDIA

Publications:
•  Serum Lycopene in Type 2 Diabetes with microalbuminuria and its correlation with endothelial dysfunction . Sikdar S, Anuradha S, Singh NP, Prakash A, Agarwal SK. Indian Heart Journal 2003 55:561-570 Abstract no 416 Read more.

•  Lycopene supplemenattion in Losartan treated normotensive Type 2 diabetes mellitus patients with microalbuminuria and its effect on endothalial function markers. Sikdar S, Agarwal SK , Prakash A, Anuradha S, Singh NP. J Assoc Physicians India Dec 2003 51:1163 Abstract no 51 Read more.

•  Lycopene Supplementation in Losartan Treated Elderly Type 2 Diabetes Mellitus Patients with Microalbuminuria and its Effect on Endothelial Function Markers. SK Agarwal, V Sahni, NP Singh, S Anuradha, S Sikdar, A Gahlot, A Wadhwa. J Assoc Physicians India 2005 53: 233-234 Read more.

•  Effects of Lycopene on Lipid Peroxidation and Glycemic Control in Normotensive Type 2 Diabetes Mellitus Patients. S Anuradha, SK Agarwal, NP Singh, A Gahlot, A Yadav, A Makhija, V Shani. J Assoc Physicians India 2005 53: 233-234
Read more.

•  Effects of Atorvastatin and Lycopene on Endothelial Function and Lipid Peroxidation in Normotensive Type 2 Diabetes Mellitus Patients with Microalbuminuria. A Gahlot, SK Agarwal, NP Singh, UK Makwane, TK Misha, A Yadav, A Makhija. J Assoc Physicians India 2005 53: 233-234 Read more.


Awards:
1 st Prize with GOLD MEDAL at APICON 2004 in the diabetes section Read more.

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TRIAL 17:

Investigator:
Dr. SK Gupta, Head of Dept. (Pharmacology), AIIMS, New Delhi, INDIA

Publications:
•  Lycopene prevents sugar-induced morphological changes and modulates antioxidant status of human lens epithelial cells. Mohanty I, Joshi S, Trivedi D, Srivastatva S, Gupta SK. Br J Nutr 2002; 88: 347-354 Read more.

•  Lycopene attenuates Oxidative Stress Induced Experimental Cataract Development: An In Vitro and In Vivo Study. Gupta SK, Trivedi D, Srivastatva S, Joshi S, Halder N, Verma SD. Nutrition 2003, 19: 791-799 Read more.

•  Prevention of cataract development by lycopene: an experimental study. Trivedi D, Srivastava S, Gupta SK. Indian Journal of Pharmacology 2001, 33(3): 242 Read more.

•  Lycopene a natural antioxidant protects against cataractous changes in lens epithelial cells. Trivedi D,
Mohanty I, Srivastava S, Gupta SK. Indian Journal of Pharmacology 2001, 33(3): 241-242 Read more.

MORE CLINICAL TRIALS ARE UNDERWAY IN VARIOUS
DIFFERENT INDICATIONS