Development and Clinical evaluation of analgesic activity of Tamraparna extracted Gelin Parikartika - A Randomized Controlled clinical trial

Parikartika[i]means the person who feels kartanavat peeda in Guda region which can be correlated to Fissure-in-ano[ii]. It is a painful condition characterized by a longitudinal tear in anoderm of distal anal canal which extends from anal verge proximally towards, but not beyond, dentate line[iii]. Increased incidence of this condition can be attributed to various factors including changes in lifestyle, improper dietary habits and sedentary lifestyles leading to constipation and the passage of hard stools, which can result in tears in the mucous membrane.

Symptoms of fissure-in-ano typically include severe cutting pain during and/or after defecation, along with bleeding. The location and prevalence of fissures can differ between males and females, 95% of anal fissures in males are posterior and 5% are anterior whereas 80% of anal fissures in females are posterior and 20% are anterior fissures[iv].

In contemporary medical practice, there are several treatment options available for fissure-in-ano. Local application of lignocaine gel can help in relieving the pain. Additionally, procedures such as anal sphincter dilatation or fissurectomy may be adopted as surgical options to address the fissure and alleviate symptoms[v].

It is important for individuals experiencing symptoms of fissure-in-ano to seek   medical attention for proper diagnosis and treatment, as this condition can significantly impact quality of life if left untreated.

Tamraparna is one of such drug  which has multiple pharmacological actions. Tamraparna (*Nicotiana tabacum.*Linn) has Kapha, Vata shamakaproperties[vi],[vii],[viii],[ix]. Tamraparna (Nicotiana tabacum.Linn)  has an anaesthetic[x], analgesic and anti-inflammatoryeffects[xi].

One previous study has investigated the efficacy of Tobacco leaves extract as an anaesthetic agent on Clarias gariepinus juveniles and adults, as it induces anaesthesia within 3 minutes and recovery within 9 minutes with no mortalityby diffusion through well vascularised skin to the body[xii]. The skin, gills & oesophagus of fish are lined by mucosa having stratified epithelial cells [xiii] [xiv]. The mucosa of anal canal [xv] and  buccal cavity [xvi]are lined by stratified squamous epithelium cell.

Other studies revealed that TAMRAPARNA (Nicotiana tabacum.Linn) has an analgesic and wound healing effect in recurrent aphthous ulcers[xvii].

So with this background extract of Tamraparna (Nicotiana tabacum. Linn)  is being taken up for the present study

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[i]Vasant C Patil and Dr. Rajeshwari N.M (1st Ed.), Sushrut Samhita of Acharya Sushrut, Chikitsa Sthana; Vamana Virechana Vyapat: chapter 34: Chaukhambha Publications, 2018; pg no 576.

[ii] Norman S Williams, P.RONAN O’Connell, Andrew W.McCaskie. Bailey & Love’s short practice of surgery,27th edition: CRC Press, Taylor & Francis Group, 2018, 74th chapter, pg no 1351.

[iii] Norman S Williams, P.RONAN O’Connell, Andrew W.McCaskie. Bailey & Love’s short practice of surgery,27th edition: CRC Press, Taylor & Francis Group, 2018, 74th chapter, pg no 1351.

[iv] Sriram Bhatt M, Manual of Surgery, 7th Edition 2023, reprint:2024, pg no.-1036.

[v] K Rajgopal Shenoy, Manipal Manual of Surgery, Fourth Edition: CBS Publishers & Distributors,   pg no 803-804.

[vi] Shri Narhari Pandit’s  RAJ NIGHANTU by Dr. Satish Chandra Sankhyadhar, Jai Krishnadas Ayurveda Series no.158, Chaukhambha Publications, reprint edition:2017,chapter-5,Parpatadi Varga, pg no.-155.

[vii] Shri LaxmipatiShastri , Yogaratnakar**,**first edition :2020,Chaukhambha Publications, chapter 1, pg no.-41.

[viii] Shri Bappalaal vaidya, Adharsha Nighantu, reprinted in year 2005, Popular Prakashan Private Limited,1976,pg no.-146-149.

[ix] Shri Hari Parishistha bhaga, Shaligram Nighantu, printed in 2002, Khemraji Shri Krishan Das Publications, pg no.-908-909.

[x] Mashood K.Mustapha and Jamaldeen A.Aileru, Efficacy of Tobbacco leaves Nicotinia tabaccum as Anaesthesic agent on the juveniles and Adults of African Catfish Clarias gariepinus(Burchell1822)

https://scholar.archive.org/work/3pimshtamnci7fmchfoaa7sqoe/access/wayback/https://www.sciendo.com/pdf/10.2478/ast-2021-0007

 [xi] Kamal Kishore, MONOGRAPH OF TOBACCO (NICOTIANA TABACUM) ,Department of Pharmacy, M.J.P. Rohilkhand University, Bareilly-243006, U.P., Indian Journal of Drugs, 2014, 2(1), 5-23

[xii] Mashood K.Mustapha and Jamaldeen A.Aileru, Efficacy of Tobbacco leaves Nicotinia tabaccum as Anaesthesic agent on the juveniles and Adults of African Catfish Clarias gariepinus(Burchell1822)

[xiii] Ashraf Sayed Awaad, Usama Kamal Moawad, and Mohamed Gomaa Tawfiek, Comparative     Histomorphological and Histochemical Studies on the Oesophagus of  Nile Tilapia Oreochromisniloticus and African Catfish Clarias gariepinus, Hindawi Publishing Corporation Journal of Histology Volume 2014, Article ID 987041, Received 21 June 2014; Accepted 19 October 2014; Published 10 November 2014 https://downloads.hindawi.com/archive/2014/987041.pdf.

[xiv] Alaa El-Din H. Sayed, Imam A. Mekkawy and Usama M. Mahmoud, Histopathological Alterations in some Body Organs of Adult Clarias gariepinus (Burchell, 1822) Exposed to 4-Nonylphenol,  Zoology Department, Faculty of Science, Assiut University, Assiut, Biology Department, Faculty of Science, Taif University, Taif, Egypt ,Saudi Arabi

https://books.google.com/books?hl=en&lr=&id=YuOZDwAAQBAJ&oi=fnd&pg=PA163&dq=Histopathological+Alterations+in+some++Body+Organs+of+Adult+Clarias+gariepinus++(Burchell,+1822)+Exposed+to+4-Nonylphenol+&ots=KiLBxSh24p&sig=zqB7sp2jUypKx9O_L8hLK_JRevg.

[xv] Norman S Williams, P.RONANO’Connell, AndrewW.Mc Caskie. Bailey & Love’s short practice of surgery. 27th edition: CRC Press, Taylor& Francis Group,2018, 74th chapter, pg no 1340-1341

[xvi] Dr. Dingari Lakshman Chary. The Shalakya Tantra. New Delhi: Chaukhamba Sanskrit Pratishthan, 2016, Part II, pg no 208

[xvii] Siavash Vaziri, Mahdi Mojarrab, Mohammad Hosein Farzaei, Farid Najafi, Ali Ghobadi ,Evaluation of anti-aphthous activity of decoction of Nicotiana tabacum leaves as a mouthwash: a placebo-controlled clinical study, J Tradit Chin Med 2016 April 15; 36(2): 160-164 https://www.sciencedirect.com/science/article/pii/S025462721630022X.