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CTRI Number  CTRI/2024/09/074129 [Registered on: 20/09/2024] Trial Registered Prospectively
Last Modified On: 04/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effective Management Of Anal Fissure Through Ashwagandhadi Lepa 
Scientific Title of Study   A Randomised Controlled Trial To Evaluate The Effect Of Ashwagandhadi Lepa In The Management Of Parikartika (Fissure in ano) 
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 Ravendra Kumar Tiwari 
Designation  Post Graduate Scholar 
Affiliation  Sri Jayendra Saraswathi Ayurveda College and hospital chennai ,Tamilnadu 
Address  Department of Shalya Tantra, Room no.8,OPD block Sri Jayendra Saraswathi Ayurveda college and hospital Nazarathpet,Chennai,Tamilnadu

Thiruvallur
TAMIL NADU
600123
India 
Phone  9009144999  
Fax    
Email  drrktiwari2022@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr T Udayakiran 
Designation  Professor and HOD, Department of PG studies in shalya Tantra 
Affiliation  Sri Jayendra Saraswathi Ayurveda College and hospital chennai ,Tamilnadu 
Address  Department of Shalya Tantra, Room no.8,OPD block Sri Jayendra Saraswathi Ayurveda college and hospital Nazarathpet,Chennai,Tamilnadu

Thiruvallur
TAMIL NADU
600123
India 
Phone  9849666054  
Fax    
Email  dr_tenneti@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Ravendra Kumar Tiwari 
Designation  Post Graduate Scholar 
Affiliation  Sri Jayendra Saraswathi Ayurveda College and hospital chennai ,Tamilnadu 
Address  Department of Shalya Tantra, Room no.8,OPD block Sri Jayendra Saraswathi Ayurveda college and hospital Nazarathpet,Chennai,Tamilnadu

Thiruvallur
TAMIL NADU
600123
India 
Phone  9009144999  
Fax    
Email  drrktiwari2022@gmail.com  
 
Source of Monetary or Material Support  
Sri Jayendra Saraswathi Ayurveda College And Hospital Nazarathpet ,Chennai,Tamilnadu Pin-600123 
 
Primary Sponsor  
Name  Dr Ravendra Kumar Tiwari 
Address  Sri Jayendra Saraswathi Ayurveda College And Hospital Nazarathpet ,Chennai,Tamilnadu Pin-600123 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ravendra Kumar Tiwari  Sri Jayendra Saraswathi Ayurveda College And Hospital Chennai  Department Of Shalya Tantra ,Room No.8,OPD Block, Sri Jayendra Saraswathi Ayurveda College Hospital Chennai
Thiruvallur
TAMIL NADU 
9009144999

drrktiwari2022@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Sri Jayendra Saraswathi Ayurveda College and Hospital,Department of Ayurveda SCSVMV,Nazarathpet,Chennai-600123  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: PARIKARTIKA, (2) ICD-10 Condition:K602||Anal fissure, unspecified. Ayurveda Condition: PARIKARTIKA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-lepa, लेप (Procedure Reference: Bhaishajya Ratnavali Chapter 47 Vrana Sotha Chikitsa Prakranam,Vanagasen Chikitsa Sarasamgraha Vol.2 Chapter 54 Vrana Shotha Chikitsa, Procedure details: The patient will be taken to lie down in the lithotomy position, inspection and palpation will be done. Digital examination will be done and anal region will be cleaned with an antiseptic solution and the required quantity of Ashwagandhadi lepa wiil be taken and apply digitally or through an applicator. the dressing will be done after the application of the lepa. )
(1) Medicine Name: Ashwagandhadi Lepa, Reference: Bhaishajya Ratnavali Chapter 47 Vrana Sotha Chikitsa Prakranam,Vanagasen Chikitsa Sarasamgraha Vol.2 Chapter 54 Vrana Shotha Chikitsa, Route: Topical, Dosage Form: Lepa Churna, Dose: 2(g), Frequency: od, Duration: 15 Days
2Comparator ArmProcedure-lepa, लेप (Procedure Reference: Bhaishajya Ratnavali Chapter 47 Vrana Sotha Chikitsa Prakranam,, Procedure details: The patient will be taken to lie down in the lithotomy position, inspection and palpation will be done. The digital examination will be done and the anal region will be cleaned with an antiseptic solution and the required quantity of Jatyadi Ghrita wiil be taken and applied digitally or through an applicator. the dressing will be done after the application of the lepa. ))
(1) Medicine Name: Jatyadi Ghrita, Reference: Bhaishajya Ratnavali Chapter 47 Vrana Sotha Chikitsa Prakranam,, Route: Topical, Dosage Form: Ghrita, Dose: 2(g), Frequency: od, Duration: 15 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Subjects diagnosed with the clinical sign and symptoms of Parikartika. 
 
ExclusionCriteria 
Details  Known cases of inflammatory bowel diseases, Severe anal stenosis, Patients diagnosed with malignancy, Patients diagnosed with AIDS, Hepatitis B 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Complete healing of the parikartika vrana (Fissure wound)  15 days 
 
Secondary Outcome  
Outcome  TimePoints 
Complete healing of the Fissure wound without any complications.  After completion of the study and wound healing (vrana), patients will be advised to follow up in 30 and 45 days. 
 
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/ Phase 3 
Date of First Enrollment (India)   23/09/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  
One of the most prevalent anorectal diseases, Fissure in ano, is caused by a longitudinal tear in the anoderm beneath the dentate line. In this condition defecation is painful, and there is a streak of bleeding on the stool. It affects both males and females equally and is common in all age groups. Most of the fissures heal by conservative means but a significant proportion turn chronic, negatively impacting a patient’s overall quality of life. It has been reported that the yearly incidence is 1.1 per 1000 persons, which translates to a 7.8% lifetime risk1. Most patients with fissures are middle-aged or younger, with a mean onset of 39.9 years2. Anal fissure incidence is seen to be rather high in Chennai due to the hot climate and a diversified diet. According to studies done at the Government Medical College Tirunelveli Tamil Nadu on patients with anorectal diseases who were chosen at random, 30.7% had anal fissures3. The treatment options for chronic fissures are generally based on reducing the anal pressures and include non-surgical and surgical modalities. Out of the various treatment modalities available, need for a simple, cost-effective, non-invasive treatment should be adopted which goes with day to day life of the patient. In the conventional method to reduce pain, such as a sitz bath, topical anesthetics, steroids, and analgesics are used as supporting measures. Surgical treatments such as Lords Anal dilatations, posterior sphincterotomy5, fissurotomy6, lateral internal sphincterotomy 7, excision of the anal canal, and anal advancement of the flap8 often produce practical difficulties for the patient. External Applications such as Ropana taila, Pichu, Matra Basti, Varti, Ksharakarma, Kshara sutra and Lepa are explained. Ashwagandhadi Lepa is one of the such modality which has the property of healing the Vrana9. The main ingredients of Ashwagandhadi lepa are Ashwagandha, Katuki, Lodhra, Katphala, Madhuyashti, Manjistha & Flowers of Dhataki.
Previous research work done by “Sikandan A, Shinomiya T, Nagahara Y(2018), Division of Life Science and Engineering, School of Science and Engineering, Tokyo Denki University, Hatoyama, Japan.
Ashwagandha root extract exerts anti-inflammatory effects in HaCaT cells and regulating cytokines, International journal of molecular medicine.” This study reveals the anti-inflammatory activity of Ash-wex
on the skin, by using the human keratinocyte cell line HaCaT. The result indicates that Ash-wex significantly works on anti-inflammation and ulcer healing10.
Most of the ingredients of Ashwagandhadi lepam have anti-inflammatory, analgesic, and ulcer-healing properties. More over compared to modern modalities it is cost-effective, non-irritant, easily available, and convenient medicine. Goghritam has Madhur Rasa, Guru, Snigdha, Mridu Guna, Sheeta Veerya, VataPittaharam11, and Vrana Ropana properties12.So, There is the need to evaluate the effect of Ashwagandhadi Lepa with Ghrita (Trial Drug) and compare with Jatyadi Ghrita (as the standard of care) and as an external application in Fissure in Ano along with Triphala Churnam as a common laxative for both groups.
 
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