| CTRI Number |
CTRI/2025/11/097123 [Registered on: 10/11/2025] Trial Registered Prospectively |
| Last Modified On: |
08/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [OPEN CLINICAL] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Testing an ayurvedic ointment prapoundarikadi ghrita for quick relief in patients with acute anal fissure |
|
Scientific Title of Study
|
Effect of prapoundarikadi ghrita ointment 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 |
SAFEENA V M |
| Designation |
PG SCHOLAR |
| Affiliation |
GAVC TRIPUNITHURA |
| Address |
PG Scholar
Salyatantra Department
Government Ayurveda College
Tripunithura
PG Scholar
Salyatantra Department
Government Ayurveda College
Tripunithura
Ernakulam
KERALA
682301
India |
| Phone |
9048554090 |
| Fax |
|
| Email |
safeenav.moideenkutty@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHAFEER M S |
| Designation |
ASSISTANT PROFESSOR GAVC TRIPUNITHURA |
| Affiliation |
GAVC TRIPUNITHURA |
| Address |
Assistant Professor
Salyatantra Department
Government Ayurveda College
Tripunithura
Assistant Professor
Salyatantra Department
Government Ayurveda College
Tripunithura
Ernakulam
KERALA
682301
India |
| Phone |
9447524691 |
| Fax |
|
| Email |
shafeermudavankattil@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHAFEER M S |
| Designation |
ASSISTANT PROFESSOR GAVC TRIPUNITHURA |
| Affiliation |
GAVC TRIPUNITHURA |
| Address |
Assistant Professor
Salyatantra Department
Government Ayurveda College
Tripunithura
Ernakulam
Assistant Professor
Salyatantra Department
Government Ayurveda College
Tripunithura
Ernakulam
Ernakulam
KERALA
682301
India |
| Phone |
9447524691 |
| Fax |
|
| Email |
shafeermudavankattil@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda college
Dhanvantri Nagar
Puthiyakavu
Tripunithura
Kerala, India
Ernakulam
682301
|
|
|
Primary Sponsor
|
| Name |
Government Ayurveda College |
| Address |
Dhanvantri Nagar
Puthiyakavu
Tripunithura
Ernakulam
Kerala, India
682301
|
| Type of Sponsor |
Government medical college |
|
|
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 |
| Safeena V M |
Government Ayurveda College Tripunithura Ernakulam Kerala |
OPD 4 and IPD Department of Salyatantra, Government Ayurveda college Tripunithura,
Dhanvantri Nagar, Puthiyakavu, Ernakulam, Kerala, India
682301
Ernakulam
KERALA |
9048554090
safeenav.moideenkutty@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL COMMITTEE FOR ETHICS IN RESEARCH |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: PRAPOUNDARIKADI GHRITA OINTMENT, Reference: CHAKRADUTTA, Route: Topical, Dosage Form: Ghrita, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: -REFERENCE-CHAKRADUTTA INGRIENTS-Prapoundarika, manjishta,madhuka,usheera,pattangam,haridra,go ghrita, go ksheera, bee wax
prepare ghrita using drugs by sneha paaka vidhi then made to ointment form. kalka 1/4part, ghrita-1part,milk 4part water-4part. for oinment prapoundarikai ghrita 6parts bee wax 1part. instruct the patient to apply twice daily |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Acute Anal fissure diagnosed by clinical examination
Participants with age limit of 18-40
Participants with written informed consent |
|
| ExclusionCriteria |
| Details |
Fissure in ano in colorectal carcinoma,crohns disease, ulcerative colitis, tuberculosis . |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
objective parameters
1)wound healing- grading
2)tenderness- grading |
objective parameters will assess on 0th day (before starting the treatment),
7th day(1st week) of treatment started and 14th day (2nd week)of treatment started.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
subjective Parameter
1)pain assessed by VAS |
Subjective assesment will be done on 0th day,7th day,and 14th day. |
subjective parameter
pain by VAS |
asssessed on 0th day (before starting the treatment),7th day (1st week) of treatment started,14th day(2nd week) of treatment. |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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 3 |
|
Date of First Enrollment (India)
|
30/11/2025 |
| 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="0"
Months="8"
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
|
In this study Prapoundarikadi ghrita mentioned in chakradutta made to ointment form .Ingridients are prapoundarika, manjishta, pattangam, madhuka,usheera,haridra, go ghrita, go ksheera,bee wax.Topical application of ointment instruct to the patient and results assessed in 0th,7th and 14th days. This study is to assess the effect of prapoundarikadi ghrita ointment in acute fissure in ano. |