A SINGLE-BLIND, PLACEBO-CONTROLLED CLINICAL TRIAL OF LOCAL APPLICATION OF KOHL-CHIKNI DAWA-A UNANI COMPOUND FORMULATION IN THE PATIENTS OF PRE-MATURE SENILE CATARACT
DOI:
https://doi.org/10.22159/ajpcr.2024v17i12.51304Keywords:
Kohl Chikni Dawa, Pre-mature senile cataracts, Lens score, Loss of visionAbstract
Objective: The present clinical trial was undertaken to evaluate the safety, preventive/ curative efficacy of the local application of KCD in patients of premature senile cataract, to provide an economic, safe, and effective alternative treatment for it.
Methods: The present prospective single-blind, placebo-controlled trial was undertaken at Majeedia Hospital, Hamdard University, New Delhi. The diagnosed patients of premature senile cataract were randomly allocated to three groups for local application of KCD/ placebo.
Results: Ninety two patients completed the study period of 6 months. After treatment the results show that KCD was effective in the general amelioration of the signs, and symptoms of the premature senile cataract. KCD have some significant effect on grade I of PS Cataract as out of 52 cases; lens score was nil in 5 patients (9.6 %) but no effect on grades II and III premature senile cataract. Vision remains stationary in 44% cases during study period.
Conclusion: The dose of KCD in two sticks BID was safe, and tolerable with no side effects. KCD was also effective in loss of vision in grade I of PSC. KCD have potential to modulate the progress of early premature senile cataract. A multicentric trial of the test drug on a larger sample size for a longer duration of five years as per WHO recommendation is required to establish the efficacy of the formulation on premature senile cataract.
Downloads
References
Naidoo K, Kempen JH, Gichuhi S, Braithwaite T, Casson RJ, Cicinelli MV, et al. Prevalence and causes of vision loss in sub-Saharan Africa in 2015: Magnitude, temporal trends and projections. Br J Ophthalmol. 2020;104(12):1658-68. doi: 10.1136/ bjophthalmol-2019-315217, PMID 32229517
Ruiss M, Findl O, Kronschläger M. The human lens: An antioxidant-dependent tissue revealed by the role of caffeine. Ageing Res Rev. 2022;79:101664. doi: 10.1016/j.arr.2022.101664, PMID 35690384
Thylefors B, Négrel AD, Pararajasegaram R, Dadzie KY. Global data on blindness [WHO bulletin]. Bull World Health Organ. 1995;73(1):115- 21. PMID 7704921
Vajpayee RB, Joshi S, Saxena R, Gupta SK. Epidemiology of cataract in India: combating plans and strategies. Ophthalmic Res. 1999;31(2):86- 92. doi: 10.1159/000055518, PMID 9933769
Barbara G. Green Pharmacy. London: Jill Noman and Hobhouse; 1981. p. 313-75.
Sreelakshmi V, Abraham A. Age related or senile cataract: Pathology, mechanism and management. Austin J Clin Ophthalmol. 2016;3(2):1067.
Ilajul Amraz KM, Matba Mujtabaee D. 1903:75.
Bayaz-e-Kabir KM. Vol. 2. Hyderabad: Hikmat Book Depo; 1938. p. 111.
Anonymous. National Formulary of India. Part I. MH: Department of Indian Medicine & New Delhi: FW GOI; 1981. p. 58-62.
Sasaki K, Shibata T, Obazavz H, Fujiwara T, Kogure F, Obara Y, et al. Classification system of cataracts. Ophthalmic Res. 1990;22 Suppl 1:46-50.
Kabiruddin M. Bayaz-e-Kabir. Vol. 3. Hyderabad: Hikmat Book Depo; 1921. p. 37.
Ghosh MK, Mitra D, Banerjee AK, Roy IS. Clinical evaluation of an indigenous herbal eye drops preparation [preliminary report]. Indian Pract. 1985;38:1149-53.
Mitra AK, Gupta AK, Debdas M. Clinical observations on an herbal eye drops preparation. Antiseptic. 1986; :567-69.
Nagata M, Kojima M, Sasaki K. Effect of vitamin E eye drops on naphthalene induced cataract in rats. J Ocul Pharmacol Ther. 1999 Aug;15(4):345-50. doi: 10.1089/jop.1999.15.345, PMID 10463873
Kabiruddin M. Bayaz-e Kabir. Vol. 1. Hyderabad: Hikmat Book Depo; 1935. p. 43.
Siddiqui TA, Shadab Z, Nishat I, Ayesha N, Zehra Z, Alvi SH. Ocular safety assessment of Kohl Chikni Dawa-a compound formulation of Unani medicine with special reference to Draize test in rabbits. Acta Manilana. 2001;49:41-7.
Zehra Z, Nazir S. A single-blind, placebo-controlled clinical trial of local application of Kohl-Chikni Dawa-a Unani Compound formulation in the patients with Corneal Opacity. Asian J Pharm Clin Res. Nov 2022;15(11):47-51. doi: 10.22159/ajpcr.2022v15i11.44717.
Lee EH, Wan XH, Song J, Kang JJ, Cho JW, Seo KY, et al. Lens epithelial cell death and reduction of anti-apoptotic protein Bcl-2 in human anterior polar cataracts. Mol Vis. 2002;8:235-40. PMID 12118239
Balaji M, Sasikala K, Ravindran T. Copper levels in human mixed, nuclear brunescence, and posterior subcapsular cataract. Br J Ophthalmol. 1992 Nov;76(11):668-69. doi: 10.1136/bjo.76.11.668, PMID 1477042
Cook CS, McGahan MC. Copper concentration in cornea, iris, normal, and cataractous lenses and intraocular fluids of vertebrates. Curr Eye Res. 1986;5(1):69-76. doi: 10.3109/02713688608995168, PMID 3082599
Swanson AA, Trusedale AW. Elemental analysis in normal and human cataract lens tissue. Biochem Biophys Res Commun. 1971 Dec 17;45(6):1488-96. doi: 10.1016/0006-291x (71)90188-4
Rácz P, Erdöhelyi A. Cadmium, lead and copper concentration in normal and senile cataractous human lenses. Ophthalmic Res. 1988;20(1):10-3. doi: 10.1159/000266248, PMID 3380522
Nath R, Srivastava SK, Singh K. Accumulation of copper and inhibition of lactate dehydrogenase activity in human senile cataractous lens. Indian J Exp Biol. 1969;7(1):25-6. PMID 5771164
Gupta SK, Selvan VK, Agrawal SS, Saxena R. Advances in pharmacological strategies for the prevention of cataract development. Indian J Ophthalmol. 2009 May-Jun;57(3):175-83. doi: 10.4103/0301- 4738.49390, PMID 19384010
Siddiqui TA, Shadab Z, Nishat I, Ayesha N, Zehra Z, Alvi SH. Effect of Kohl Chikni Dawa a compound ophthalmic formulation of Unani medicine on naphthalene induced cataract in rats. BMC Complement Altern Med. 2002;2:1-4. doi: 10.1186/1472-6882-2-13
Siddiqui TA, Shadab Z, Nishat I, Ayasha N, Zehra Z, Alavi SH. Anti-Cataract activity of Kohl Chikni Dawa-a compound ophthalmic formulation of Unani medicine in alloxan diabetic rats. J Ethnopharmacol. 2003;86(1):109-12. doi: 10.1016/s0378- 8741(03)00046-1, PMID 12686448
Siddiqui TA, Shadab Z, Nishat I, Ayesha N, Alvi SH. Protective effect of Kohl-Chikni Dawa against galactose-induced cataract in rats. Adv Tradit Med. 2004;4(2):82-6. doi: 10.3742/OPEM.2004.4.2.082
Bustanul Mufredat HA, Book Depo Z. Delhi. 1893;127(172):222.
Makhzanul Mufredat KM. 1951;203(294):394.
Ai SS, Mufreda UA, Taraqqi Urdu Beauru GO. New Delhi; 1993. p. 317.
Sasaki K, Hockwin O, Sakamoto Y, Sasaki H, Kojima M. High hurdles of clinical trials to demonstrate efficacy of anticataractogenic drugs. Ophthalmologica. 2000;214(6):390-98. doi: 10.1159/000027531, PMID 11053998
Published
How to Cite
Issue
Section
Copyright (c) 2024 Zehra Khatoon Zaidi
This work is licensed under a Creative Commons Attribution 4.0 International License.
The publication is licensed under CC By and is open access. Copyright is with author and allowed to retain publishing rights without restrictions.