| CTRI Number |
CTRI/2024/08/072679 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
14/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Topical Application ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Topical Application On Fissure In Ano |
|
Scientific Title of Study
|
A Randomized Control Trial On Application of Tiladi Lepam in the Management of Parikartika (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 Jaya Shankari S |
| Designation |
Post Graduate Scholar |
| Affiliation |
Sri Jayendra Saraswati Ayurveda College and Hospital |
| Address |
Department of Shalya Tantra Sri Jayendra Saraswati Ayurveda College and Hospital Nazarethpet Chennai
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
9600199691 |
| Fax |
|
| Email |
subijaya21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T Udaya kiran |
| Designation |
Professor HOD |
| Affiliation |
Sri Jayendra Saraswati Ayurveda College and Hospital |
| Address |
Department of Shalya Tantra Sri Jayendra Saraswati Ayurveda College and Hospital Nazarethpet Chennai
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
9849666054 |
| Fax |
|
| Email |
dr_tenneti@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jaya Shankari S |
| Designation |
Post Graduate Scholar |
| Affiliation |
Sri Jayendra Saraswati Ayurveda College and Hospital |
| Address |
Department of Shalya Tantra Sri Jayendra Saraswati Ayurveda College and Hospital Nazarethpet Chennai
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
9600199691 |
| Fax |
|
| Email |
subijaya21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Jayendra Saraswati Ayurveda College and Hospital Nazarethpet Chennai 600123 |
|
|
Primary Sponsor
|
| Name |
Dr Jaya Shankari S |
| Address |
Department of Shalya Tantra Sri Jayendra Saraswati Ayurveda College and Hospital Nazarethpet Chennai 600123 Tamilnadu India |
| 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 |
| Dr Jaya Shankari S |
Sri Jayendra Saraswati Ayurveda College and Hospital |
Room no 8 Department of Shalya Tantra Sri Jayendra Saraswati Ayurveda College and Hospital Nazarethpet Chennai 600123
Thiruvallur
TAMIL NADU |
9600199691
subijaya21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Sri Jayendra Saraswati Ayurveda College and Hospital |
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 | Procedure | - | Lepam | (Procedure Reference: Sushruta samhita , Procedure details: Poorva
Pradhana Karma:
Patients anal region will be cleaned with antiseptic solution.
Inspection will be done. Digital examination will be done.
Required quantity of Tiladi lepam will be taken and applied manually.)
(1) Medicine Name: Tiladi lepam, Reference: Chakradatta, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: od, Duration: 14 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Pain during defecation
Passage of fresh blood or bright streaks of blood along with stool
Hypertonicity assessed by digital examination |
|
| ExclusionCriteria |
| Details |
Patients diagnosed cases of crohns disease diverticulitis ulcerative colitis
Severe anal stenosis
Congenital anomalies of rectum and anal canal
Patients diagnosed with malignancy
Immuno compromised patients suffering from HIV Syphilis TB
Uncontrolled Diabetes mellitus and Hypertension
Localised infection
Pregnant women |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reducing pain
Arrest bleeding
To attain normal tonicity |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To improve the quality of life |
15 days |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/01/2025 |
| 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="3"
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 characterised by pain and burning sensation in the anal region. This condition can be correlated with Parikartika. In the present scenario, incidence of anal fissure is very high, due to unhealthy food habits. The prevalence of anal fissure is around 18% in India. In Chennai, due to intake of spicy food and mixed dietary habits, the patients with anal fissure are found to be very high. This is a very common condition in Shalya tantra OPD of SJSACH. There are various treatment modalities in modern medicine for Fissure in Ano. The need for a simple, cost effective, patient friendly method is necessary. In Ayurveda, various treatment ways are available for Parikartika (Fissure in Ano), where 85% of results are observed in conservative management.
Tiladi lepam is a non-irritant, easily available and very convenient to use. The ingredients of Jatyadi tailam like haridra, karanja are kustaghna and krimighna and hence it can be attributed to check wound infection. The Neem and Daruharidra of Jatyadi taila are proven drugs to check bacterial growth and promotes wound healing.
This is a Randomized Control study to evaluate the efficacy of Tiladi lepam and Jatyadi tailam in Parikartika. |