| CTRI Number |
CTRI/2025/03/083213 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
23/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Establish The Kampillak Ghrut Pichu As Effective Treatment In The Management Of Parikartika With Special Reference To Acute Fissure In Ano. |
|
Scientific Title of Study
|
A Randomised Controlled Clinical Trial To Evaluate The Efficacy Of Kampillak Ghrut Pichu In Parikartika With Special Reference To Acute Fissure In Ano |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rohit Baban Jadhav |
| Designation |
PG Scholar |
| Affiliation |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Islampur |
| Address |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute
And Reserch Centre Islampur Department Of Shalyatantra Division
No 1 Room No 1 Tal Walwa
Sangli
MAHARASHTRA
415409
India |
| Phone |
07875724949 |
| Fax |
|
| Email |
drrohitjadhav.4949@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shubhangini Suresh Nagaralmath |
| Designation |
Associate professor Shalyatantra Department |
| Affiliation |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Islampur |
| Address |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute
And Reserch Centre Islampur Department Of Shalyatantra Division
No 1 Room No 1 Tal Walwa
Sangli
MAHARASHTRA
415409
India |
| Phone |
7709677061 |
| Fax |
|
| Email |
shubhasn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rohit Baban Jadhav |
| Designation |
PG Scholar |
| Affiliation |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Islampur |
| Address |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute
And Reserch Centre Islampur Department Of Shalyatantra Division
No 1 Room No 1 Tal Walwa
Sangli
MAHARASHTRA
415409
India |
| Phone |
07875724949 |
| Fax |
|
| Email |
drrohitjadhav.4949@gmail.com |
|
|
Source of Monetary or Material Support
|
| LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Islampur Tal Walwa Dist Sangli 415409 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Dr Rohit Baban Jadhav |
| Address |
Department Of Shalyatantra LRP Ayurvedic Medical College And
Hospital Post Graduate Institute And Research Centre urun Islampur
Tal Walwa Dist Sangli 415409 Maharashtra 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 Rohit Baban Jadhav |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Reserch Centre |
Department of Shalyatantra Division no-1 Room no-1 LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Reserch Centre Islampure Tal Walwa Dist Sangli 415409 Maharashtra India
Sangli
MAHARASHTRA |
07875724949
drrohitjadhav.4949@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Reserch Centre Islampur |
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 | Procedure | - | picu, पिचु | (Procedure Reference: charak chikistha 25/93, Procedure details: sitz bath for 3-5 min after in lithotomy position after sterile gauze soaked in kampillak ghruita & placed at anal canal for 2-3 hr )
(1) Medicine Name: kampillak ghruita, Reference: charak chikistha 25/93, Route: Rectal, Dosage Form: Ghrita, Dose: 10(ml), Frequency: od, Duration: 15 Days | | 2 | Comparator Arm | Procedure | - | picu, पिचु | (Procedure Reference: bhaishajya ratnavali adhyaya 53, Procedure details: sitz bath for 3-5 min after in lithotomy position after sterile gauze soaked in jatyadhi ghrita & placed at anal canal for 2-3 hr )
(1) Medicine Name: jatyadhi ghrita , Reference: bhaishajya ratnavali adhyaya 53, Route: Rectal, Dosage Form: Ghrita, Dose: 10(ml), Frequency: od, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with age group between 18-50 years of age .
2.Patients with Acute fissure in ano presenting with complaints of Bleeding per Rectum, Pain, Pruritis, Burning sensation at anal region
and with or without constipation.
3. Patients with Post Partum women (if there is no any specific drug
allergy) will be selected .
4.Patients will be selected irrespective of Gender, Religion, Education
And Socio Economic status. |
|
| ExclusionCriteria |
| Details |
1.Patients having fissure in ano Secondary to Koch’s, Crohn’s
disease, Ulcertaive Colitis, CA Rectum , Anal Stricture.
2.Patients with Chronic fissure in ano with Sentinel pile and
Associated with condition like Haemorroids , Fistula in ano,
malignancy of rectum anal canal, rectal prolapsed ,Liver disease .
3.Patients with known case of Systemic disorders such as
Uncontrolled DM,Severe Anaemia, Bleeding disorder(Coagulopathy) |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To Establish the ‘Kampillak Ghrut Pichu’ as effective treatment in the
management of Parikartika with special reference to Acute fissure in
Ano. |
Pichu is applied on the daily basis for 15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Conceptual study of Parikatika according to Ayurvedic Literature
Elaborate study of Acute Fissure in Ano.
To study the efficacy of Jatyadi ghrut in parikartika
To analyse the results of trial group with standard group |
Pichu is applied on the daily basis for 15 days follow ups on 17th , 20th, 23rd ,
25th and 29th Day |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
03/04/2025 |
| 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
|
Kampillak
Has particularly has stanik Vranshodhan And Vranropak properties
also along with it Goghrut is mixed which also has Vrana Shodhan
and vrana ropak properties and also a characteristic property called
as sanskaranuvartini which doubles the properties of drug to get the
desired result .
As Parikartika (Fissure-In-Ano) is a longitudinal tear which resembles
to a Vran. Kampillak ghrut will help in healing the Vran.
Objective:
Primary Objective:
To Establish the ‘Kampillak Ghrut Pichu’ as effective treatment in the
management of Parikartika with special reference to Acute fissure in
Ano. Secondary objectives:
• Conceptual study of Parikatika according to Ayurvedic Literature
• Elaborate study of Acute Fissure in Ano.
• To study the efficacy of Jatyadi ghrut in parikartika
• To analyse the results of trial group with standard group .
The Study Includes 100 Patients which are randomly divided into
50-50 each .
Group A & Group B .
Group A – Treated with KAMPILLAK GHRUT pichu
Group B – Treated With JATHYADHI GHRUT pichu
29days (Regular Dressing 15 days With follow ups on 17th , 20th, 23rd ,
25th and 29th Day)
Assessment Criteria :
1)SUBJECTIVE PARAMETERS:-
• Kartanavat vedana (Cutting type of pain)
• Daha (Burning sensation in Anal Region)
• Gudagat Raktastrav after defecation (Blood Streak along stool)
• Guda Kandu (Itching)
• Constipation (Mal-Vibandha) 2) OBJECTIVE PARAMETERS:-
• Number of the Fissures
Observations and Results: Data obtained from the follow up chart
and other observations will be used and the results will be drawn on
the basis of various charts, graphs, and tables.
Discussion: The collected data will be analyzed and the therapeutic
use of Kampillak ghrut and Jatyadighrut in Parikartika with special
reference to Fissure in ano will be analysed and compared.
Summary: The research study will be summarized in brief on the
basis of above result. |