| CTRI Number |
CTRI/2025/05/087555 [Registered on: 26/05/2025] Trial Registered Prospectively |
| Last Modified On: |
24/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of panchavalkala kera thailam as anal instillation in acute fissure in ano |
|
Scientific Title of Study
|
A Clinical study to evaluate the
effect of Panchavalkala kera thaila 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 |
Dr Sreejith satheesan |
| Designation |
Associate professor Department of shalyatantra |
| Affiliation |
Pankajakasthuri Ayurveda Medical College and Post Graduate Centre |
| Address |
Department of shalyatantra Pankajakasthuri Ayurveda Medical College and Post Graduate Centre Kattakada Thiruvananthapuram kerala 695572 India
Thiruvananthapuram
KERALA
695572
India |
| Phone |
9447791353 |
| Fax |
|
| Email |
dr.sreejith.satheesan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Athira Mohan T |
| Designation |
PG Scholar |
| Affiliation |
Pankajakasthuri Ayurveda Medical College and Post Graduate Centre |
| Address |
Department of shalyatantra Pankajakasthuri Ayurveda Medical College and Post Graduate Centre Kattakada Thiruvananthapuram kerala 695572 India
Thiruvananthapuram
KERALA
695572
India |
| Phone |
08592811353 |
| Fax |
|
| Email |
athiramthiruthoor@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Athira Mohan T |
| Designation |
PG Scholar |
| Affiliation |
Pankajakasthuri Ayurveda Medical College and Post Graduate Centre |
| Address |
Department of shalyatantra Pankajakasthuri Ayurveda Medical College and Post Graduate Centre Kattakada Thiruvananthapuram kerala 695572 India
Thiruvananthapuram
KERALA
695572
India |
| Phone |
08592811353 |
| Fax |
|
| Email |
athiramthiruthoor@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pankajakasthuri Ayurveda medical college and PG centre, Kattakada Thiruvananthapuram, kerala, India Pin 695572 |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [student funded MS PROJECT] |
|
|
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 Athira Mohan T |
Pankajakasthuri Ayurveda Medical College and Post Graduate Centre |
Department of shalyatantra Pankajakasthuri Ayurveda Medical College and Post Graduate Centre Kattakada Thiruvananthapuram kerala 695572 India
Thiruvananthapuram
KERALA |
8592811353
athiramthiruthoor@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Pankajakasthuri Ayurveda Medical College and PG centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: PARIKARTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | vaitaraNa-bastiH, वैतरण-बस्तिः | (Procedure Reference: CHARAKA SIDHI 6/67, Procedure details: The participants are selected according to the sampling technique following assessment criteria. The selected participants will be given Panchavalkala Kerataila as anal instillation once daily during morning hours for 7 days.
Materials Required
Panchavalkala Kerataila, cotton swab, Panchavalkala Kashaya , sterile cotton pad, sterile gauze, surgical gloves, kidney tray, 20ml syringe, Sterile rubber catheter no.3, Sponge holding forceps, Torch.
Purva karma
The participants are instructed to come after proper evacuation of stool & urine, followed by intake of a light diet, half an hour before the intervention. Patient is given sitz bath for 15 minutes with Triphala Kashayam prior to the procedure.
Pradhana karma
Patient will be made to lie in left lateral position (Sim’s position). Panchavalkala Kerataila will be instilled with 20ml syringe, which is connected to the distal end of sterile rubber catheter. Catheter will be lubricated with same medicine and Panchavalkala Kerataila will be introduced into anal canal gently
)
(1) Medicine Name: PANCHAVALKALA KERATHAILA, Reference: BHAVAPRAKASA NIGHANTU, Route: Rectal, Dosage Form: Taila, Dose: 20(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Subjects within age group of 18 to 50 years
Subjects recruited irrespective of gender fulfilling diagnostic criteria of acute Fissure in ano mentioned above
Subjects willing to sign consent form
|
|
| ExclusionCriteria |
| Details |
Fissure in ano secondary to diseases like Crohns disease Tuberculosis Syphilis Ulcerative colitis malignancy etc
Subjects with known case of carcinoma of rectum
Subjects with uncontrolled Diabetes Mellitus and Hypertension
Pregnant ladies
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the effect of anal instillation with Panchavalkala Kerataila in acute Fissure in ano
To evaluate the effect of anal instillation with Panchavalkala Kerataila in acute Fissure-in-ano
Assessment of ulcer in ano, pain, bleeding from fissure at baseline, 8th day and follow up on 15th and 22nd day. |
To assess the effect of anal instillation with Panchavalkala Kerataila in acute Fissure in ano
Assessment of ulcer in ano, pain, bleeding from fissure at baseline, 8th day and follow up on 15th and 22nd day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="31"
Sample Size from India="31"
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)
|
06/06/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
A CLINICAL STUDY TO EVALUATE THE EFFECT OF PANCHAVALKALA KERATHAILA IN ACUTE FISSURE IN ANOFissure in Ano is an elongated ulcer in long axis of lower anal canal. In acute fissure, there will be spasm of anal sphincter muscle, pain on defecation, and passage of bright streaks of blood after passing stool. The signs and symptoms of fissure in ano can be compared with parikartika as per Ayurveda. Management of this condition includes vatanulomana, shoolahara and vranaropana measures. The drug of choice in present study is Panchavalkala which is mentioned in Bhavaprakasa Nighantu. The aim of the study is to assess effect of anal instillation with panchavalkala kerathailam in Acute fissure in Ano. This will be a single arm pre test and post test clinical trial. 31 participants diagnosed with acute fissure in ano within age group of 18 to 50 years satisfying inclusion and exclusion criteria will be selected from Pankaja Kasthuri Ayurveda Medical college hospital. The selected participants will be managed by anal instillation with Panchavalkala kerathaila for 7days. Assessment of ulcer in ano, pain and bleeding from fissure is done on before treatment, 8th day, and follow up on 15th and 22nd day. The data collected will be analyzed statistically using approppriate statistical techniques |