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CTRI Number  CTRI/2024/07/069873 [Registered on: 04/07/2024] Trial Registered Prospectively
Last Modified On: 27/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Management of Acute Fissure by Yavadi Ghritam (locally) and Haritakichurna Vati (internally).  
Scientific Title of Study   A clinical study to evaluate the efficacy of Yavadi Ghritam (Locally) along with Haritakichurna Vati (internally) in the management of Parikartika w.s.r. 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  Abhinav Dubey 
Designation  PG Scholar 
Affiliation  Dr D Y Patil Deemed to be university PATIL DEEMED TO BE UNIVERSITY NERUL NAVI MUMBAI  
Address  D Y Patil deemed to be University School of Ayurveda Department of Shalya Tatra OPD no 3

Thane
MAHARASHTRA
400706
India 
Phone  7880412241  
Fax    
Email  abhikan2107@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Amarprakash Dwivedi 
Designation  Professor 
Affiliation  Dr D Y Patil deemed to be university  
Address  D Y Patil deemed to be University School of Ayurveda Department of Shalya Tatra OPD no 3

Thane
MAHARASHTRA
400706
India 
Phone  9323097013  
Fax    
Email  amar.dwivedi@dypatil.edu  
 
Details of Contact Person
Public Query  
Name  Dr Amarprakash Dwivedi 
Designation  Professor 
Affiliation  Dr D Y Patil deemed to be university  
Address  D Y Patil deemed to be University School of Ayurveda Department of Shalya Tatra OPD no 3

Thane
MAHARASHTRA
400706
India 
Phone  9323097013  
Fax    
Email  amar.dwivedi@dypatil.edu  
 
Source of Monetary or Material Support  
D Y Patil deemed to be University School of Ayurveda Department of Shalya Tatra OPD no 3 Sector 8 Nerul Navi Mumbai India 400706 
 
Primary Sponsor  
Name  Dr Abhinav Dubey 
Address  D Y Patil deemed to be University School of Ayurveda Department of Shalya Tatra OPD no 3 Sector 8 Nerul Navi Mumbai India 400706 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Abhinav Dubey  D Y Patil Ayurvedic Hospital   D Y Patil deemed to be University School of Ayurveda Department of Shalya Tatra OPD no 3
Thane
MAHARASHTRA 		 7880412241

abhikan2107@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee D Y Patil Deemed to be university, School of Ayurveda, Navi Mummbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K600||Acute anal fissure. Ayurveda Condition: PARIKARTIKA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Yavadi Ghritam, Reference: Vangsen Sam Vol2 Chap 54/92 page 687, Route: Topical, Dosage Form: Ghrita, Dose: 3(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: post defecation
(2) Medicine Name: Haritakichurna Vati, Reference: Sha sam pratham khand 4/3-4, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -luke warm water), Additional Information:
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patient of Acute Fissure in Ano will be included in this study.

2. Age Group between 18 to 60 yrs (irrespective of gender).

3. All the cases will be fresh/new who have not received any local treatment.
 
 
ExclusionCriteria 
Details  1.Chronic Fissure in Ano (Onset more than 28 days) with Sentinel Tag & Anal papillae.

2.Bleeding Disorder like Hemophilia etc.

3.Patient with uncontrolled systemic disease like diabetes and hypertension.

4.Patient with Ca rectum.

5.Pregnant women, Debilitated person & patient suffering from Pittaja roga.

6.Patient having Parikartika, secondary to Ulcerative colitis, Syphilis, Crohn’s disease, T.B.,
HIV, Hepatitis etc.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Parameters such as Gudagata Shool (Pain) , Gudagata Rakta Strava (P/R bleeding), Malavastabh (Constipation), Anal Sphincter Spasm and Anal Ulcer will be observed on 0-3 scale to access therapeutic outcome
 		 Improvement in Clinical Symptoms in Parameters will be observed on day 1, day3 , day 5, day 7 and 14 day of treatment.


 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   25/07/2024 
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  

Title of study- 

“ A clinical study to evaluate the efficacy of Yavadi Ghritam (Locally) along with Haritakichurna Vati (Internally) in the management of Parikartika w.s.r. to Acute Fissure in Ano.

Aim: To evaluate the efficacy of Yavadi Ghritam (Locally) along with Haritakichurna Vati (internally) in the management of Parikartika w.s.r. to Acute Fissure in Ano.

Objectives:

To evaluate the effect of Yavadi Ghritam (Locally) in the management of Symptoms such as burning sensation, pain, anal sphincter spasm, ulcer, bleeding P/R and Haritakichurna Vati (internally) in the management of constipation.

To To establish Yavadi ghritam as cost effective local formulation, easily available and completely herbal preparation without adverse effects for Parikartika w.s.r. to Acute Fissure in Ano.

Tt  To review the Ayurvedic and modern literature in context to Parikartika w.s.r. Acute fissure in ano and adavancement in its management.

  Research Question-

Whether Yavadi Ghritam (Locally) along with Haritakichurna Vati (Internally) effective in management of Parikartika w.s.r to Acute Fissure in Ano.

Hypothesis-

Null Hypothesis (H0)-Yavadi Ghritam (Locally) along with Haritakichurna Vati (Internally) is not effective in management of Parikartika w.s.r to Acute Fissure in Ano.

Alternate Hypothesis(H1)-Yavadi Ghritam (Locally) along with Haritakichurna Vati (Internally) is effective in management of Parikartika w.s.r to Acute Fissure in Ano.

 Methodology-

Source of Data – D.Y Patil Ayurvedic hospital, Navi Mumbai, Shalya Tantra dept., OPD No- 03

Type of study – Open, single arm, Clinical Study

Ethical clearance – Ethical clearance will be taken from ethical committee of Dr. D.Y Patil  Ayurvedic Hospital.

Consent- A understanding will be given to the patients about trial and a written consent will be taken  from the patient prior to participate in study.

Sample size – 50 patients

Material/Drug –

       1.Local Use-Yavadi Ghritam

       2.Internal Use- Haritakichurna Vati

Doses-Local application of Yavadi Ghritam with the help of applicator daily for 7 days (in morning before & after defecation & in night before sleeping hours).

Internally Haritakchurna Vati (500mg each) 4 tablets at night for 14 days.

Anupan- Koshn Jal (Lukewarm water).

Diagnostic Criteria-

               1)Gudagata Shool (Pain).

                         2) Gudagat Rakta strava (P/R Bleeding).

                         3)  Malavstambh(constipataion)                                                       

                         4) Anal sphincter spasm      

                          5) Anal Ulcer Healing

 Follow up-1,7,14, 21, 28 Day

Method of Preparation of Ghrita-

Ingredients-  1)Yava Coarse powder +Yastimadhu Coarse powder (1:1) - 1 part

2)   Murchhita Ghrita & Til Taila (3/4 Parts Ghrita+1/3 Part Til Taila) – 4 Parts

3)   Water-16 PartS

PREPARATION-Preparation of Yavadi Ghritam will be done a/c Sushruta samhita chikitsha sthana chapter-31/8. First, Prepare Yavadi (Yava+Yashtimadhu) Kwath as per authentic procedures of preparation. Store the coarse powder of Yavadi (Yava+Yashtimadhu) in a vessel and soak with water then boil with 16 times of water until it reduces to a quarter. Take Til Taila and Ghrita suitable pot and heat separately on the flame untill the Sneha Siddhi is achieve. Do Til Taila  and Ghrita murchhana and allow it to cool by itself. Then 1 Part of kwath will be add into 1 part of Til Taila and Ghrita (1/4 Til Taila +3/4 Ghrita) and allow mandagni till madhyam pak awashtha is achieve. Then, processed Ghrita will be sieve and collect processed Ghrita in a clean and sterile container.

                   

                 PREPARATION OF HARITAKICHURNA VATI-

 

·   Raw dried fruit of Haritaki will be taken and its seeds will be removed. Then processing of  the Haritaki Churna (powder) will be done. (a/c to sa. m. 6/1) then Vati measuring 500mg

each will be prepared from the powder.

 

 



 

 

 

 

 

       

 

 
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