| CTRI Number |
CTRI/2025/06/088427 [Registered on: 09/06/2025] Trial Registered Prospectively |
| Last Modified On: |
09/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
Comparative Study on the Effectiveness of Ashwatha Ointment and Ashwatha Oil in Management Acute Anal Fissures |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL TRIAL TO EVALUATE THE EFFICACY OF ASHWATHA OINTMENT AND ASHWATHA TAIL ON PARIKARTIKA WITH SPECIAL REFERENCE TO 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 Anuja Nana Pagar |
| Designation |
M.S. Scholar Shalyatantra Samanya Departmen |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalaya |
| Address |
Department of Shalyatantra Samanya, Shree Saptashrungi Ayurved Mahavidyalaya,Kamal nagar Hiravadi, Panchavati, Nashik, Maharashtra 422003 India
Nashik
India
Nashik
MAHARASHTRA
422003
India |
| Phone |
9623777474 |
| Fax |
|
| Email |
anujapagar97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh Ahire |
| Designation |
Professor |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalaya |
| Address |
Department of Shalyatantra Samanya, Shree Saptashrungi Ayurved Mahavidyalaya,Kamal nagar Hiravadi, Panchavati, Nashik, Maharashtra 422003 India
Nashik
MAHARASHTRA
422003
India |
| Phone |
9623843106 |
| Fax |
|
| Email |
ramesh.v.ahire@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramesh Ahire |
| Designation |
Professor |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalaya |
| Address |
Department of Shalyatantra Samanya, Shree Saptashrungi Ayurved Mahavidyalaya,Kamal nagar Hiravadi, Panchavati, Nashik, Maharashtra 422003 India
Nashik
MAHARASHTRA
422003
India |
| Phone |
9623843106 |
| Fax |
|
| Email |
ramesh.v.ahire@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shalyatanta department,OPD no. 1,Shree Saptashrungi Ayurved Mahavidyalaya And Hospital , KamalNagar , Hirawadi , Panchwati, Nashik Maharashtra 422003 |
|
|
Primary Sponsor
|
| Name |
Department of Shalyatantra Shree Saptashrungi Ayurved Mahavidyalaya |
| Address |
Department of Shalyatantra Samanya, Shree Saptashrungi Ayurved Mahavidyalaya,Kamal nagar Hiravadi, Panchavati, Nashik, Maharashtra 422003 India |
| Type of Sponsor |
Private 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 |
| Dr Anuja Nana Pagar |
Shree Saptashrungi Ayurved Mahavidyalaya And Hospital |
Department of Shalyatantra Samanya, Shree Saptashrungi Ayurved Mahavidyalaya,Kamal nagar Hiravadi, Panchavati, Nashik, Maharashtra 422003 IndiaNashikIndia
Nashik
MAHARASHTRA |
09623777474
anujapagar97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Shree Saptashrungi Ayurved Mahavidyalaya Nashik Panchavati Nashik Maharashtra 422003 |
Approved |
|
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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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Ashwatha tail, Reference: Vrundamadhav , Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Samudga, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ashwatha ointment , Reference: Vrundamadhav , Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 5(mg), Frequency: bd, Bhaishajya Kal: Samudga, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Clinically diagnosed cases of Parikartika (Acute fissure in ano) will be taken for the study.
2 Patients irrespective of gender, religion, occupation & economic status.
3 Patients between the age group of 18 to 70 years.
4 Patients which agreed for treatment with informed consent. |
|
| ExclusionCriteria |
| Details |
1 Age less than 18 years and more than 70 years.
2 Patients having Parikartika (Acute Fissure-in-ano) secondary to Ulcerative colitis,Syphilis, Crohn ‘s disease, Tuberculosis and Ca of rectum and anal canal.
3 Patients with infectious diseases like HIV/ HbsAg / HCV.
4 Patient with uncontrolled Diabetes and Hypertension.
5 Patients associated with conditions like Hemorrhoids (Arsha), Fistula-in-ano (Bhagandar).
6 Patients with Perianal abscess, rectal prolapsed and severe local sepsis.
7 COPD/ Severe Bronchial Asthma.
8 Any previous anal surgery.
9 Not willing to give consent. |
|
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Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduce The Sign And Symptoms Of Acute Fissure in Ano |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To provide long term relief and reduce recurrence of Fissure in Ano |
10 days |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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)
|
24/06/2025 |
| 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 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
|
OBJECTIVES Primary • To determine the effect of Ashwatha Ointment on parikartika (Acute Fissue in Ano) • To determine the effect of Ashwatha Tail in the management on parikartika (Acute Fissue in Ano) • To compare effect of Ashwatha Ointment and Ashwatha Tail on parikartika (Acute fissure in ano) Secondary • To study Formulation Procedure of Ashwatha Ointment and Ashwatha Tail as per standard protocol.
PARTICIPANTS:-41 number of patients of each group having age between 18yrs to 70yrs suffering with sign and symptoms of Acute Fissure in Ano and meeting inclusion and exclusion criteria will be randomised And selected for study from OPD AND IPD department of shalyatantra of Shree Saptashrungi Medical College and Hospital Nashik.
INTERVENTIONS- 41 Patient In group A selected for Ashwatha ointment application 41 Patient in group B selected for Ashwatha oil application
Primary Outcome : Reduce the sign and symptoms of Acute Fissure in Ano.
Secondary outcome: Provide long term relief and reduce recurrence.
Treatment Duration : 15 Days
Follow Up :5th , 10th , 15th Days
Data Analysis : Data will be analysed using appropriate statistical methods to compare the effectiveness of the both intervension group.
Ethical Considerations : The study will be conducted in accordence with ethical guidelines and with informed consent from participents.
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