| 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 |
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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 |
|
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Details of Secondary Sponsor
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K600||Acute anal fissure. Ayurveda Condition: PARIKARTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (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 | | 2 | Intervention Arm | Drug | Other 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 |
|
|
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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
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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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. |