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CTRI Number  CTRI/2023/04/051586 [Registered on: 13/04/2023] Trial Registered Prospectively
Last Modified On: 17/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Paeonia Q for Acute Anal fissure management: An observational study 
Scientific Title of Study   Usefulness of Paeonia Officinalis Q in the management of acute anal fissure: An open-label, prospective, non-randomised, observational study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ashish Kumar Dixit 
Designation  Medical Officer (Homoeopathy) 
Affiliation  All India Institute of Medical Sciences Bhopal 
Address  Deapertment of AYUSH, AIIMS Bhopal
Deapertment of AYUSH, AIIMS Bhopal
Bhopal
MADHYA PRADESH
462020
India 
Phone    
Fax    
Email  ashish.ayush@aiimsbhopal.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Ashish Kumar Dixit 
Designation  Medical Officer (Homoeopathy) 
Affiliation  All India Institute of Medical Sciences Bhopal 
Address  Deapertment of AYUSH, AIIMS Bhopal
Deapertment of AYUSH, AIIMS Bhopal

MADHYA PRADESH
462020
India 
Phone    
Fax    
Email  ashish.ayush@aiimsbhopal.edu.in  
 
Details of Contact Person
Public Query  
Name  Ashish Kumar Dixit 
Designation  Medical Officer (Homoeopathy) 
Affiliation  All India Institute of Medical Sciences Bhopal 
Address  Deapertment of AYUSH, AIIMS Bhopal
Deapertment of AYUSH, AIIMS Bhopal

MADHYA PRADESH
462020
India 
Phone    
Fax    
Email  ashish.ayush@aiimsbhopal.edu.in  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences Bhopal 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences 
Address  Saket Nagar Bhopal 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  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 Ashish Kumar Dixit  AIIMS Bhopal   Room Number 1, Department of AYUSH, AIIMS, Saket Nagar, Bhopal
Bhopal
MADHYA PRADESH 		 9599834711

ashish.ayush@aiimsbhopal.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee, AIIMS Bhopal  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Paeonia Officinalis Q  Intervention is planned as administration of Paeonia Officinalis, a homoeopathic medicine orally in mother tincture (Q). Mother tincture will be given 10 drops mixed with 50 ml of water once a day (OD) orally in the morning half an hour before breakfast as standard guidelines mentioned in Homoeopathic Pharmacopoeia of India (HPI) and duration of such treatment will be of 3 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Subjects must be 18 years and above with moderate health.
2. Subjects with 4 weeks (28 days) or less history of painful acute anal fissure (AF), prior to screening, where AF-related pain-associated with, or following, defecation is experienced at least twice a week during the symptomatic phase.
3.Subjects with an average of equal or more than of 4 on a 10-point VAS scale during the screening phase for worst anal pain associated with, or following, defecation for the most recent 3 days on which the subject has defecated.
4. Subjects with evidence of a radial fissure; seen on anal examination.
5.Subjects who are not taking any other concomitant oral/topical preparations applied perianally prior to commencing study treatment, and throughout the study.
6. Able to give consent
 
 
ExclusionCriteria 
Details  ï‚· Subjects, who are unwilling to be examined for AF.
ï‚· Subjects have undergone a sphincterotomy or anal stretch or other previous interventions involving the anal canal or perianal region ï‚· Subjects having multiple fissures will be excluded. ï‚· Who have had sub-fissure injection of botulinum toxin within 6 months period or used glyceryltrinitrate (GTN) ointment for > 1 week in the 4 weeks prior to the screening visit
ï‚· Severely immuno-compromised patients for example patients with history of HIV infection, patients with solid organ transplantation or bone marrow transplantation, patients receiving chemotherapy/radiotherapy, patients with primary immunodeficiency, treatment with oral or intravenous steroids.
ï‚· Have cardiovascular disease, fixed anal stenosis/fibrosis or severe haematological illness like Sickle cell disease.
ï‚· Pregnant women. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
VAS for Pain  Baseline, 2, 4, 8 and 12 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
Defecation Strain Score  Baseline, 2, 4, 8 and 12 weeks. 
Healing of Fissure  4, 8 and 12 weeks 
ORIDL score  2, 4, 8 and 12 weeks 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/04/2023 
Date of Study Completion (India) 15/04/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 15/04/2024 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Anal fissure (AF), as a prevalent cause of excruciating anal pain, is one of the most common anorectal problems observed in clinical practice. Nowadays, a lot offolks who have this condition use alternative therapies. The efficacy of homoeopathic remedies for AF is asserted, however reports often include other ano-rectal problems. The proposed study will look at the usefulness of Paeonia Officinalis Q, a homeopathic medicine in the management of anal fissures. This will be a prospective, open-label, non-randomized, observational, single-center pre-post comparison design study that shall be carried out at the homeopathic outpatient department (OPD), AIIMS Bhopal, and the sample size will be 40 (after calculation). Administration of Paeonia Officinalis is planned orally in mother tincture (Q) form. It will be given 10 drops mixed with a half cup of water once a day (OD) orally as per standard guidelines mentioned in Homoeopathic Pharmacopoeia of India (HPI) and the duration of such treatment will be of 3 months. The study objectives are; to assess the efficacy Paeonia Officinalis Q for pain and healing of fissure (HoF) and safety chiefly. The outcome parameters are VAS for pain, healing of fissure, Defecation strain score (DSS), and ORIDL scale will be measured at different times during the study period. The analysis shall be carried out with per protocol approach. Data distribution shall be examined by Shapiro Wilk test for normality. The baseline descriptive data (categorical and continuous) will be presented in terms of absolute values and percentages, means and standard deviations. Parametric or non-parametric inferential test will be planned as per the normality of data distribution comparing dependent observations of continuous outcomes at baseline and after 3 months of intervention. P values less than 0.05 will be considered as significant. SPSS®-IBM® v. 20 for windows will be used for analysis of data. This study may open new avenues for the management of AF as a non-surgical, cost-effective, alternative therapy.
 
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