| CTRI Number |
CTRI/2025/03/082133 [Registered on: 11/03/2025] Trial Registered Prospectively |
| Last Modified On: |
11/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
ACTION OF CHANDANADI TAILA PICHU IN ANAL FISSURE |
|
Scientific Title of Study
|
A Randomised Comparative Clinical Study To
Evaluate The Efficacy Of Chandanadi Taila And
Yastimadhu Taila Pichu 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 Irshan Ahamed A |
| Designation |
PG Scholar |
| Affiliation |
Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduate Centre |
| Address |
SDM Trusts Ayurvedic Medical College Danigond Post Graduate
Centre And Padma Ayurvedic Hospital And Research Centre Dr Siddhant Nagar Terdal Shalya Dept 2nd Floor Room No 1
SDM Trusts Ayurvedic Medical College Danigond Post Graduate
Centre And Padma Ayurvedic Hospital And Research Centre Dr Siddhant Nagar Terdal Shalya Dept 2nd Floor Room No 1
Bagalkot
KARNATAKA
587315
India |
| Phone |
9108630319 |
| Fax |
|
| Email |
irshan2409999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ISHWAR KATTEWADI |
| Designation |
Professor |
| Affiliation |
Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduate Centre |
| Address |
SDM Trusts Ayurvedic Medical College Danigond Post Graduate
Centre And Padma Ayurvedic Hospital And Research Centre Dr
Siddhant Nagar Terdal Shalya Dept 2nd Floor Room No 1
Bagalkot
KARNATAKA
587315
India |
| Phone |
8123999487 |
| Fax |
|
| Email |
ishwarsk208@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Irshan Ahamed A |
| Designation |
PG Scholar |
| Affiliation |
Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduate Centre |
| Address |
SDM Trusts Ayurvedic Medical College Danigond Post Graduate
Centre And Padma Ayurvedic Hospital And Research Centre Dr
Siddhant Nagar Terdal Shalya Dept 2nd Floor Room No 1
Bagalkot
KARNATAKA
587315
India |
| Phone |
9108630319 |
| Fax |
|
| Email |
irshan2409999@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDMTs Ayurvedic Medical College and Padma Ayurvedic Hospital Institutional Ethics Committee
for Research on Human Subjects
Shalya Dept 2nd Floor Room No 1 Terdal 587315 Karnataka India |
|
|
Primary Sponsor
|
| Name |
Dr Irshan Ahamed A |
| Address |
SDM Trusts Ayurvedic Medical College Danigond Post Graduate
Centre And Padma Ayurvedic Hospital And Research Centre Dr Siddhant Nagar Terdal 587315 Karnataka 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 Irshan Ahamed A |
Padma Ayurvedic Hospital And Research Centre |
OPD Department of
SHALYA TANTRA
Ground Floor Padma
Ayurvedic Hospital And
Research Centre Terdal
Bagalkot
KARNATAKA |
9108630319
irshan2409999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDMTs Ayurvedic Medical College And Padma Hospital INSTITUTIONAL ETHICS COMMITTEE FOR RESEARCH ON HUMAN SUBJECTS |
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, (2) ICD-10 Condition:K92||Other diseases of digestive system. Ayurveda Condition: PARIKARTIKA, (3) ICD-10 Condition:K628||Other specified diseases of anus and rectum. Ayurveda Condition: PARIKARTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: chandanadi taila , Reference: sushruta samhita, chikitsa sthan ch 2/36, Route: Rectal, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: yashtimadhu taila, Reference: sushrut samhita, chikitsa sthan ch 6/12, Route: Rectal, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
• Patients with classical sign and symptoms of Parikartika.
• Patients will be selected in the age group between 18-60 years.
• Pregnancy and lactating women |
|
| ExclusionCriteria |
| Details |
• Patients suffering with any associated Ano rectal disease like fistula-in-Ano,
polyps or piles.
• Patients with K/C/O Crohn’s disease, Ulcerative colitis, syphilis and other
systemic disease pertaining to rectum and anal canal.
• HIV, HBsAg, TB patients.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of chandanadi taila pichu Over parikartika(fissure in ano) Assessed By The Assessment Parameter |
0th Day 7th day 15th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To see The long Term Effect Of chandanadi taila Over parikartika( Fissure In Ano) Assessed By Assessment Parameter
2) To rule out adverse drug reaction if any
3) To study the recurrence rate of parikartika after the drug intervention |
0th Day 7th day 15th Day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
22/03/2025 |
| 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
|
Parikartika is one among the anorectal diseases. The possible reasons include trauma to the anoderm caused during defecation of hard stools due to low fiber diet, sedentary lifestyle are the contributing factors for the development of anal fissure. The prevalence rate among patients with fissure in Ano is 18% that to more common in women’s, young and middle-aged individuals. The word Parikartika is mentioned in Basti karma vyapath and Vamana Virechana Vyapath. Parikartika means “Parikartanavat Vedana” excruciating cutting type of pain around anal region .
Parikartika mentioned among the symptoms of Vataja Atisara , Vataja Grahani , Purisha Udavarta , Arsha Poorvarupa . According to classics, the different treatment modalities such as Bheshaja, Shashtra, Kshara Karmas are mentioned. The modern science includes laxatives, soothing ointments, and surgical approach like fissurectomy, anal sphincterotomy, V-Y advancement flap is told but these procedures have their own limitations and possibility of reoccurrence and risk of formation of abscess or fistula .
This shows the area where ayurvedic treatment modalities are easy to perform, effective, affordable and safe. In this present study Pichu is employed to be the treatment approach.
This study aims to evaluate the efficacy of Chandanadi Taila Pichu over Yastimadhu Taila Pichu in the management of Parikartika(Fissure in ano). |