| CTRI Number |
CTRI/2025/10/096216 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
29/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Combined effect of application of analsuppository using ayaparnakera and internal administration of vara powder in tear in analcanal for reducing pain,burning sensation,bleeding,wound size |
|
Scientific Title of Study
|
combined effect of topical application of ayaparnakera varthi and internal administration of vara churna in 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 |
Akhila K |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda college Pariyaram Kannur |
| Address |
Department of shalyatantra
Government Ayurveda college Pariyaram Kannur Kerala
Department of shalyatantra
Government Ayurveda college Pariyaram Kannur
Kannur
KERALA
670503
India |
| Phone |
8848772392 |
| Fax |
|
| Email |
akhilaanand97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Gangadharan |
| Designation |
Professor and HOD |
| Affiliation |
Government Ayurveda college Pariyaram Kannur |
| Address |
Department of shalyatantra
Government Ayurveda college Pariyaram Kannur
Department of shalyatantra
Government Ayurveda college Pariyaram Kannur
Kannur
KERALA
670503
India |
| Phone |
9496777170 |
| Fax |
|
| Email |
drkganga@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akhila K |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda college Pariyaram Kannur |
| Address |
Department of shalyatantra
Government Ayurveda college Pariyaram Kannur
Department of shalyatantra
Government Ayurveda college Pariyaram Kannur
Kannur
KERALA
670503
India |
| Phone |
8848772392 |
| Fax |
|
| Email |
akhilaanand97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of shalyatantra
Government ayurveda college hospital pariyaram kannur,kerala,India PIN 670503 |
|
|
Primary Sponsor
|
| Name |
Akhila k |
| Address |
Pg scholar
department of shalyatantra
government ayurveda college pariyaram kannur
PIN 670503 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Akhila K |
Government ayurveda college hospital pariyaram,kannur |
OPD and IPD of department of shalyatantra
Kannur
KERALA |
8848772392
akhilaanand97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Government Ayurveda college kannur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K928||Other specified diseases of the digestive system. Ayurveda Condition: PARIKARTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ayaparna kera, Reference: Indian medicinal plants , Route: Topical, Dosage Form: Varti/ Suppository, Dose: 1(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -it is topically applied as varthi in analcanal(2) Medicine Name: Triphala churna, Reference: Bhavaprakasha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -ushnodaka), Additional Information: It is given internally with lukewarm water at bed time |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants clinically diagnosed with Acute fissure- in- Ano.
Age group between 18 to 60 years |
|
| ExclusionCriteria |
| Details |
Participants having known case of malignancy, syphilis, tuberculosis, HIV, hepatitis, Crohn’s disease, Irritable bowel syndrome, Ulcerative colitis.
Participants not willing for local application.
With fistula in Ano, rectal prolapse.
With uncontrolled diabetes mellitus |
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain,
Bleeding,
Burning sensation
Length of ulcer
|
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
constipation
anal sphincter spasm |
30 days |
|
|
Target Sample Size
|
Total Sample Size="27"
Sample Size from India="27"
Final Enrollment numbers achieved (Total)= "27"
Final Enrollment numbers achieved (India)="27" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/10/2025 |
| Date of Study Completion (India) |
22/02/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
An anal fissure is a common medical condition characterized by a small tear or crack in the lining of the anus. Acute fissure- in- Ano refers to sudden onset of symptoms often caused by trauma during bowel movements or passing hard stools. The main symptoms are sharp cutting pain & burning sensation during and after defecation, bright red blood on the toilet paper or in the stool and spasm of anal sphincters. Treatment for acute fissure in Ano focuses on relieving symptoms and promoting healing. Conservative measures include use of stool softeners, laxatives, topical analgesics, ointments etc. Signs and symptoms of fissure- in- Ano has close resemblance with the features of parikarthika. According to Ayurveda parikarthika is mentioned as a complication of atisara, improper administration of vasthi, vamana and virechana.Treatment for parikarthika as per charaka samhitha are pichavasthi, anuvasan vasthi,parisheka,pichu and local administration of Sneha dravya which relieve vata and pitta. In Ayurveda classics Ayaparna (Eupatorium triplinerve Vahl) has the properties of vrana sodhana ropana, rakthasthambana,anulomana etc;Kera taila has proven actions such as anti-inflammatory,anti-bacterial and relieving muscle spasm.Vara churna is having anulomana (mild laxative) property. It also has anti-inflammatory, anti-microbial and wound healing actions. Keeping these factors in view ayaparna kera varthi and varachurna is used to evaluate the effect in acute fissure in Ano. The present study design was open clinical study which done among 27 participants in the age group 18-60years selected from shalyatantra department of Government Ayurveda College Hospital Kannur. The study population consecutively selected in a single group and varthi applied and vara churna given internally. Treatment done on 14 consecutive days and assessment done based on objective parameters such as length of ulcer, anal sphincter spasm & subjective parameters such as pain, bleeding,burning sensation and constipation, before treatment on 0th day, in between treatment on 8th day ,after treatment on 15th day and follow up on 30th day. Statistical evaluation of the study findings confirmed that the observed clinical improvements were significant, supporting the effectiveness of the treatment protocol.
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