| CTRI Number |
CTRI/2025/10/096675 [Registered on: 30/10/2025] Trial Registered Prospectively |
| Last Modified On: |
24/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect Of Danti-Chitrakadi Tail Pichu And Kasisadi Tail Pichu In External Thrombosed Piles |
|
Scientific Title of Study
|
Comparative Clinical Study Of Danti-Chitrakadi Tail Pichu And Kasisadi Tail Pichu In Managment Of Bahya Arsha W.S.R To External Thrombosed Piles |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PRATHAMESH DATTATRAY SHELKE |
| Designation |
MS SCHOLAR SHALYATA |
| Affiliation |
Ashvin Rural Ayurved Mahavidyalaya |
| Address |
Department of shalyatantra Ashvin Rural Ayurved Mahavidyalaya Ashwi sangamner Maharashtra 422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
7977537568 |
| Fax |
|
| Email |
prathameshshelke4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Vishal Tamhane |
| Designation |
Reader |
| Affiliation |
Ashvin Rural Ayurved Mahavidyalaya |
| Address |
OPD NO 12 Department of shalyatantra Ashvin Rural Ayurved Mahavidyalaya Ashwi sangamner Maharashtra 422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9764139607 |
| Fax |
|
| Email |
vvtamhane@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Vishal Tamhane |
| Designation |
Reader |
| Affiliation |
Ashvin Rural Ayurved Mahavidyalaya |
| Address |
OPD NO 12 Department of shalyatantra Ashvin Rural Ayurved Mahavidyalaya Ashwi sangamner Maharashtra 422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9764139607 |
| Fax |
|
| Email |
vvtamhane@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ashvin Rural Ayurved Mahavidyalaya Manchi hill sangamner Maharashtra 422605 |
|
|
Primary Sponsor
|
| Name |
Ashvin Rural Ayurved Mahavidyalaya |
| Address |
Ashvin Rural Ayurved Mahavidyalaya Manchi hill sangamner District Ahmadnagar 422605 |
| 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 Prathamesh Dattatray shelke |
Ashvin Rural Ayurved Mahavidyalaya |
Opd no 12 shalyatantra department Ashvin Rural Ayurveda Mahavidyalaya sangamner District Ahmadnagar Maharashtra 422605
Ahmadnagar
MAHARASHTRA |
79775 37568
prathameshshelke4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Ashvin Rural Ayurved Mahavidyalaya sangamner Ahmadnagar Maharashtra 422605 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K00-K95||Diseases of the digestive system. Ayurveda Condition: Arsha, (2) ICD-10 Condition:K00-K95||Diseases of the digestive system. Ayurveda Condition: ARSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kasisadi Tail Pichu , Reference: Bhaisajyaratanawali arsharogadikar 111-113, Route: Topical, Dosage Form: Taila, Dose: 2(ml), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 28 Days, Reference: No, Route: NA, Dosage Form: Taila, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Danti-Chitrakadi Tail Pichu , Reference: Sushruta chikitsa 6/12, Route: Topical, Dosage Form: Taila, Dose: 2(ml), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 28 Days, Reference: No, Route: NA, Dosage Form: Taila, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age group of above 20 and below 60 years, Irrespective of
Gender, occupation or economic status .
2. Patient having sign and symptoms of Bahya Arsha with
External Thrombosed Piles.
3. Patients with External Thrombosed Piles who are ready for
pichu therapy. |
|
| ExclusionCriteria |
| Details |
1. Patient below the age of 20 years and above 60 years.
2. Congenital piles, sentinel tag,
3. Patient suffering from major diseases like DM, TB, HIV,
HbsAg.
4. Pregnant women.
5. Patients with prolapsed rectum and rectal polyp. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduce sign and Symptoms of External thrombosed piles |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduce sign & Symptoms of External thrombosed piles |
14 Days |
|
|
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 2 |
|
Date of First Enrollment (India)
|
05/11/2025 |
| 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="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
|
Aim To compare the effect of Danti chitrakadi taila pichu and Kasisadi taila pichu in the management of bahya arsha w.s.r to External thrombosed piles . Objectives 1. To Study Arsha“as per Ayurvedic texts. 2. To Study External Thrombosed Piles according to modern texts. SUBJECTIVE CRITERIA According to symptoms of “Gridhrasi “mentioned in the classics. 1. Ruja (Pain) 2. Shoth (Edema) 3. Vaivarnya (Discoloration) OBJECTIVE CRITERIA 1. Size of pile mass 2. Color of pile mass |