| CTRI Number |
CTRI/2025/08/092452 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [instillation] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of lajjalu kera as anal instillation in fissure in ano |
|
Scientific Title of Study
|
Effect of lajjalu kera in 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 |
Vyshnavi M S |
| Designation |
PG scholar |
| Affiliation |
Government ayurveda medical college pariyaram kannur |
| Address |
Government ayurveda medical college pariyaram kannur
670503
Kannur
KERALA
670503
India |
| Phone |
9074186668 |
| Fax |
|
| Email |
msvyshnavi9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Sreelekha |
| Designation |
Professor and hod |
| Affiliation |
Government ayurveda medical college pariyaram kannur |
| Address |
professor and HOD
Department of shalyatantra
Government ayurveda medical collrge pariyaram kannur
Kannur
KERALA
670503
India |
| Phone |
9447671473 |
| Fax |
|
| Email |
dr.r.sreelekha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vyshnavi M S |
| Designation |
PG scholar |
| Affiliation |
Government ayurveda medical college pariyaram kannur |
| Address |
Government ayurveda medical college pariyaram kannur
670503
Kannur
KERALA
670503
India |
| Phone |
9074186668 |
| Fax |
|
| Email |
msvyshnavi9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government ayurveda medical college pariyaram Kannur Kerala India
670503 |
|
|
Primary Sponsor
|
| Name |
Vyshnavi MS |
| Address |
Mannuparambil house muttil post
Wayanad Kerala India
673122 |
| 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 |
| Vyshnavi MS |
Vyshnavi MS |
Government ayurveda medical college hospital Pariyaram Kannur Kerala India
670503
Kannur
KERALA |
9074186668
msvyshnavi9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Government ayurveda medical college pariyaram 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: LAJJALU KERA, Reference: DHANWANTHARI NIGANDU, Route: Rectal, Dosage Form: Taila, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Weeks, anupAna/sahapAna: No, Additional Information: -Lajjalu Kera Taila was prepared following the general Snehapaka Vidhi as described in Sharangadhara Samhita, using the classical ratio of 1:4:4 (Kalka: Sneha: Drava Dravya). The raw drugs were first thoroughly washed and made into a fine Kalka (paste). To this, 4 parts of Lajjalu Kashaya were added and mixed well in a clean vessel. The mixture was then heated on a mild flame, and 1 part of coconut oil was added. Continuous stirring was maintained throughout the process to ensure uniform heating and to prevent charring. The heating was continued until Madhyama Paka (medium stage of oil preparation) was attained. Once the desired consistency was reached, the Taila was allowed to cool slightly and then filtered into clean containers for storage and use. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
The diagnosis will be confirmed by a Linear ulcer at the long axis of anal canal either at the posterior or anterior midline along with any of the two mentioned below
Pain during and after defecation in the anal region
Burning sensation after defecation
Blood streaks on the stool
Age group between 18 to 65 years |
|
| ExclusionCriteria |
| Details |
Participants with known case of Ca rectum Ca anus
Participants with fistula in ano
Known case of fissure secondary to tuberculosis Inflammatory bowel disease syphilis and
other systemic disease pertaining to Colo-rectum will be excluded from the study
Patients with diseases like HIV & Hepatitis B
Bleeding disorders
Patients with uncontrolled DM |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain,
Bleeding
Burning sensation
Sphincter spasm
length of ulcer |
assessment on 0th 8th 15th day
assessment on 30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
20/08/2025 |
| 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 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
|
Fissure-in-ano is a painful anorectal condition commonly causing bleeding per rectum and affecting a large portion of the population. It can be acute, with recent tears and sphincter spasm, or chronic, with inflamed and scarred margins. While acute cases may heal with conservative measures like sitz baths and topical agents, chronic fissures often require surgical treatment, which may lead to complications such as bleeding or incontinence. In Ayurveda, the condition is correlated with Parikartika, described with symptoms like cutting pain, burning sensation, and difficulty in defecation. Classical treatments include Pichabasti, Anuvasana Basti, and application of medicated oils to pacify Vata and Pitta. This study evaluates the effect of Lajjalu Kera Taila—a formulation using Lajjalu (Mimosa pudica), known for its wound-healing and hemostatic properties, and Kera Taila (coconut oil), which is anti-inflammatory and lubricating. anal instillation of lajjalu kera done for 14 days in 30 patients aged 18–65 years with fissure-in-ano at Government Ayurveda College, Pariyaram. The results showed significant reduction in symptoms, suggesting that this Ayurvedic approach is a safe, effective, and economical alternative to conventional surgical management. |