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CTRI Number  CTRI/2025/03/083525 [Registered on: 26/03/2025] Trial Registered Prospectively
Last Modified On: 12/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [curative]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To evaluate the efficacy of Nyagrodadi Rectal Suppository in the management of Acute Fissure in Ano 
Scientific Title of Study   A Randomized Control Trial to evaluate the efficacy of Nyagrodadi Rectal Suppository in the management of Parikartika with special reference to Acute 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 Shridevi 
Designation  Post Graduate student  
Affiliation  BVVS Ayurved Medical College and Hospital Bagalkot  
Address  Department of Shalya tantra BVVS Ayurved Medical College and Hospital Bagalkot 587101
BVVS Ayurved Medical College and Hospital Bagalkot 587101
Bagalkot
KARNATAKA
587101
India 
Phone  8431600002  
Fax    
Email  shridevi9980@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Yogesh S Kulkarni  
Designation  Professor and HOD 
Affiliation  BVVS Ayurved Medical College and Hospital Bagalkot  
Address  Department of shalya tantra BVVS Ayurved Medical College and Hospital Bagalkot
BVVS Ayurved Medical College and Hospital Bagalkot
Bagalkot
KARNATAKA
587101
India 
Phone  9886664541  
Fax    
Email  dryogesh6@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mallikarjun S Hiremath  
Designation  Professor and Incharge principle 
Affiliation  BVVS Ayurved Medical College and Hospital Bagalkot  
Address  Department of Rachana Shareera BVVS Ayurved Medical College and Hospital Bagalkot
BVVS Ayurved Medical College and Hospital Bagalkot
Bagalkot
KARNATAKA
587101
India 
Phone  9482631399  
Fax    
Email  malikdost4u@gmail.com  
 
Source of Monetary or Material Support  
BVVS Ayurveda Medical College and Hospital India, Bagalkot, Karnataka 587101 
 
Primary Sponsor  
Name  BVVS Ayurveda Medical College and Hospital  
Address  BVVS Ayurveda Medical College and Hospital, BVVS campus Bagalkot Karnataka 587101 
Type of Sponsor  Private medical college 
 
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 shridevi  BVVS Ayurved Medical College and Hospital spital  Department of PG studies in Shalya tantra BVVS ayurveda medical College and Hospital, BVVS campus Bagalkot 587101
Bagalkot
KARNATAKA 
8431600002

shridevi9980@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bvvs ayurvedic medical College and Hospital Bagalkot   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K600||Acute anal fissure. Ayurveda Condition: PARIKARTIKA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Nygrodadi suppository , Reference: Sushruta Samhita Sutra sthana, Route: Rectal, Dosage Form: Varti/ Suppository, Dose: 2(g), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 07 Days, anupAna/sahapAna: No, Additional Information: Triphala Churna 12 gm with luke warm water
2Intervention ArmDrugOther than Classical(1) Medicine Name: Corect suppository , Reference: NA, Route: Rectal, Dosage Form: Varti/ Suppository, Dose: 2(g), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 07 Days, anupAna/sahapAna: No, Additional Information: Triphala Churna 12 gm is given with luke warm water
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients diagnosed with Parikartika (Acute Fissure-in-Ano)
2.Patients aged between 18-60 years, irrespective of gender 
 
ExclusionCriteria 
Details  1.patient diagnosed with other co-existing Anorectal diseases like haemorrhoids (3rd and 4th degree) fistula in ano and Ca rectum etc.
2.Patients of chronic fissure in ano with sentinel pile and anal papillae.
3.Patient with uncontrolled diabetes and hypertension.
4.Fissure in Ano due to systemic disorders like ulcerative colitis ,Crohns disease etc
5.Patient suffering from infectious diseases like RVD ,Syphilis ,HbsAg etc
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in size, burning sensation,bleeding per rectum and constipation  7 days 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in the size of the ulcer  7 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   27/03/2025 
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)   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   Parikartika is one of the common anorectal diseases observed in day-to-day clinical practice. Parikartika is a complication of Basti Karma, Virechana Vyapath, Atisara, Grahani and Arsharoga as mentioned in classics’ It is caused by Sthana Samshraya of vitiated Vata and Pitta Doshas in Gudapradesh. It can be co-related with fissure-in-ano of the contemporary science.

Fissure-in-ano is characterized by severe pain burning sensation during and after defecation, severe constipation, and there is a drop of blood or streak of fresh blood on stool. It occurs equally in both men and women and is common in all age group especially age group of 15-40 years".

Nowadays due to sedentary lifestyle, patients suffering from constipation and rectal diseases are quite high in number. It is most painful condition affecting the anal region. About 30-40% of the population suffers from proctologic pathologies at least once in their lives, in that anal fissure comprises of 10-15%.

The line of management in contemporary science is said to be conservative treatment and surgical intervention. The conservative treatment includes analgesics, stool softeners, soothing ointments, and anal dilation whereas surgical intervention includes Lord’s dilation, posterior fissurectomy and lateral anal sphincterotomy.

Parikartika is considered as Sadyovrana, Acharya Sushruta has mentioned Varti Prayoga in the context of Shashti Upakrama in the management of Vrana". Contemporary suppositories are slight modification of ancient formulations and medicated solid dose. Therefore, recent advances can be utilized for moulding varti into suppository.

Rectal Suppository offer patients, an option that is minimally invasive and easy to use in relieving rectal complaints. The absorption occurs at the site of administration, therefore rapid absorption with a rapid increase in plasma drug level can be achieved. For fissure, there needs to be a treatment that acts locally and systemically. Suppositories would act locally for wound healing and. systemically for hemostasis, laxative.

There are many drugs in ayurvedic Samhitas which are known to reduce pain by their Vedanasthapaka and Shoolahara properties, to heal wounds by their Vranaropana and Vranashodana properties, to stop bleeding by their Rakthastambhana and Shonitastapana properties, to reduce constipation by Deepana, Pachana and Anuloma properties". Keeping all these considerations rectal suppository is made named as Nygrodadi suppository, which is composed Nyagrodha, Udumbara, Shallaki, Yastimadhu, Rohini and Jambu and having properties like Shoolahara, Shodana, Ropana, Raktasthambana, Daha Prashamama. So, it acts as Vrana Shodhaka and Vrana Ropaka"

Corect suppository is a combination medicine which contains hydrocortisone acetate, lignocaine, zinc oxide, allantoin used to treat pain and bleeding associated with anal fissures and haemorrhoids".

Hence the present study is undertaken to evaluate and compare the efficacy of Nyagrodadi suppository and corect suppository in the management of Parikartika with special reference to Acute Fissure-in-ano.
 
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