| CTRI Number |
CTRI/2025/10/095745 [Registered on: 08/10/2025] Trial Registered Prospectively |
| Last Modified On: |
08/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of Fissure-In-Ano using Ashwagandhadi Lepa. |
|
Scientific Title of Study
|
Clinical Evaluation of Ashwagandhadi Lepa in 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 Vishal Verma |
| Designation |
Professor |
| Affiliation |
Rishikul Campus, Haridwar. |
| Address |
OPD No-7, Department of Shalya Tantra, Rishikul Campus,Haridwar.
Haridwar, Uttarakhand Ayurved University Haridwar Uttarakhand
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9719314634 |
| Fax |
|
| Email |
vishalverma100@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishal Verma |
| Designation |
Professor |
| Affiliation |
Rishikul Campus, Haridwar. |
| Address |
OPD No-7, Department of Shalya Tantra, Rishikul Campus,Haridwar.
Haridwar, Uttarakhand Ayurved University Haridwar Uttarakhand
UTTARANCHAL
249401
India |
| Phone |
9719314634 |
| Fax |
|
| Email |
vishalverma100@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Naima Parveen |
| Designation |
PG Scholar |
| Affiliation |
Rishikul Campus, Haridwar. |
| Address |
OPD No-7, Department of Shalya Tantra, Rishikul Campus, Haridwar.
OPD- 7, Rishikul Campus, Uttarakhand Ayurved University, Haridwar, Uttarakhand.
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9719933270 |
| Fax |
|
| Email |
naimaulzakir@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD No-7, Department of Shalya Tantra, Rishikul Campus, Haridwar, Uttarakhand , India
249401 |
|
|
Primary Sponsor
|
| Name |
Uttarakhand Ayurved University |
| Address |
Uttarakhand Ayurved University, Railway Road, Harrawala, Dehradun, Uttarakhand, India, 248001 |
| 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 |
| Naima Parveen |
Rishikul Campus, Haridwar |
OPD No-7, Department of Shalya Tantra, Rishikul Campus,
Haridwar, Uttarakhand Ayurved University Haridwar Uttarakhand
249401 India
Hardwar
UTTARANCHAL |
9719933270
naimaulzakir@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Uttarakhand Ayurved University, Rishikul Campus, Haridwar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K602||Anal fissure, unspecified. Ayurveda Condition: PARIKARTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Bhaishajya Ratnawali, Procedure details: The patient will be instructed to lie down in lithotomy position. . Firstly, an antiseptic solution
will be used to clean the perianal & anal region. A Digital Rectal Examination will be
performed to verify the location of Fissure. After that, Lepa will be applied using the little finger
on Fissure site.)
|
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who have classical symptoms of Parikartika (Fissure-In-Ano).
2. Patients of age group between 16-70 years of age.
3. Patients of either sex will be selected. |
|
| ExclusionCriteria |
| Details |
1. Patients below 16 years and above 70 years of age.
2. Patients with uncontrolled DM and HTN.
3. Known cases of Malignancy, Ulcerative colitis, Crohn’s disease, Syphilis and
Tuberculosis.
4. HBsAg, VDRL, HCV and HIV positive patients. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Relief in pain and burning sensation during defecation.
Relief in itching in anal region and constipation. |
Weekly interval up to 21 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Healing of ulcer and relieving of sphincter spasm. Relief from bleeding during defecation. |
Weekly interval upto 21 days. |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
20/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/10/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
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
|
An anal fissure is a longitudinal ulcer in the anoderm of the distal anal canal, which extends from
the anal verge proximally towards, but not beyond, the dentate line. The most common site
for occurrence of an Anal fissure is the midline posterior (90%). The next most frequent situation
is the midline anteriorly. In males fissure usually occurs in the midline posteriorly (90%) and
much less common anteriorly (10%). In females, fissure on the midline posterior is common than
anterior (60:40). The relative frequency of the anterior fissures in the females may be explained
by the trauma caused by the fetal head on the anterior wall of the anal canal during delivery. An Anal fissure is either - Acute or Chronic. Constipation has been the most common etiological factor. In Fissure-in-Ano, there is a trauma
to the lower anal canal caused by the movement of hard scybalous stool. Pain will be so severe
that patient may avoid defecation for days, thus leading to worsening of the condition. This study is an interventional , open label, single group trial, CLINICAL EVALUATION OF
ASHWAGANDHADI LEPA IN PARIKARTIKA (FISSURE-IN-ANO). The case will be selected randomly from OPD/IPD of Rishikul Campus Hospital, U.A.U, Haridwar (U.K.) India. The study will be intervened under one group with local application of Ashwagandhadi Lepa, for twice a day till complete healing. Assessment criteria will be done on subjective and objective parameters. For follow up the patients will be asked to come to the OPD of Shalya tantra Department for 1 month at 15
days interval. |