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CTRI Number  CTRI/2024/07/070271 [Registered on: 09/07/2024] Trial Registered Prospectively
Last Modified On: 01/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Analgesic Activity]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Management of Pain in Fissure-in-ano by Ayurvedic Gel 
Scientific Title of Study   Development and Clinical evaluation of analgesic activity of Tamraparna extracted Gelin Parikartika - A Randomized Controlled clinical trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR PRIYA SHUKLA 
Designation  PG Scholar 
Affiliation  KLE University 
Address  Shalya Tantra Dept. KAHERs Shri BMK AMV Shahapur Belagavi, Karnataka - 590003

Belgaum
KARNATAKA
590003
India 
Phone  9557833438  
Fax    
Email  dr.priyashukla1992@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Laxmikant 
Designation  Professor 
Affiliation  KLE University 
Address  Shalya Tantra Dept. KAHERs Shri BMK AMV Shahapur Belagavi, Karnataka - 590003

Belgaum
KARNATAKA
590003
India 
Phone  09480007651  
Fax    
Email  shalyalsd@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Laxmikant 
Designation  Professor 
Affiliation  KLE University 
Address  Shalya Tantra Dept. KAHERs Shri BMK AMV Shahapur Belagavi, Karnataka - 590003

Belgaum
KARNATAKA
590003
India 
Phone  09480007651  
Fax    
Email  shalyalsd@gmail.com  
 
Source of Monetary or Material Support  
KLE Ayurveda Hospital Shahapur Belagavi Karnataka India Pin 590003 
 
Primary Sponsor  
Name  KLE Shri BMK Ayurveda Mahavidyalaya 
Address  Shalya Tantra Dept. KAHERs Shri BMK AMV Shahapur Belagavi, Karnataka - 590003 Shalya Tantra Dept. KAHERs Shri BMK AMV Shahapur Belagavi, Karnataka - 590003 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Dr Priya Shukla  Shalya Tantra Dept. KAHERs Shri BMK AMV Shahapur Belagavi, Karnataka - 590003 Shalya Tantra Dept. KAHERs Shri BMK AMV Shahapur Belagavi, Karnataka - 590003 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Laxmikant  KLE Ayurveda Hospital  OPD No. 08 & IPD Shalya Tantra Dept. Shahapur Belagavi
Belgaum
KARNATAKA 		 09480007651

shalyalsd@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Research on Human Subjects  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:O||Medical and Surgical. Ayurveda Condition: SULAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Tamra Parna Extracted Gel, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 5(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 1 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator Arm (Non Ayurveda)-Lignocane Gel5gm OD for 1 Day
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patient with Parikartika (Acute fissure-in-ano) 
 
ExclusionCriteria 
Details  Patient with the history of HIV I & II, HbsAg , uncontrolled DM & HTN, pregnancy, crohn’s disease, ulcerative colitis, carcinoma of rectum and other systematic diseases 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction of Pain in fissure-in-ano  Base line, 15min, 30min, 1hr, 3hr, 6hr, 12hr 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  N/A 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   02/09/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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 shamaka properties[vi],[vii],[viii],[ix]. Tamraparna (Nicotiana tabacum.Linn)  has an anaesthetic[x], analgesic and anti-inflammatory effects[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 mortality by 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

[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.

 

 
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