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CTRI Number  CTRI/2026/01/101338 [Registered on: 16/01/2026] Trial Registered Prospectively
Last Modified On: 02/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Homeopathic treatment of acute paronychia 
Scientific Title of Study   A double-blind, randomized, placebo-controlled trial of individualized Dioscorea villosa for the treatment of acute paronychia among adults 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1333-6013  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rajat Kumar Pal 
Designation  Professor and Head 
Affiliation  D N De Homoeopathic Medical College and Hospital 
Address  Dept of Repertory, OPD room no. PG3, 5 (Surgery), 9 (Skin), 12, Gobinda Khatick Road

Kolkata
WEST BENGAL
700046
India 
Phone  09433130996  
Fax    
Email  drrajatkumarpal@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Priyanka Sen 
Designation  Postgraduate Trainee 
Affiliation  D N De Homoeopathic Medical College and Hospital 
Address  Dept of Repertory, OPD room no. PG3, 5 (Surgery), 9 (Skin), 12, Gobinda Khatick Road

Kolkata
WEST BENGAL
700046
India 
Phone  08259024415  
Fax    
Email  priyankasen072@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shreyasi Das 
Designation  Internee 
Affiliation  D N De Homoeopathic Medical College and Hospital 
Address  Dept of Repertory, OPD room no. PG3, 5 (Surgery), 9 (Skin), 12, Gobinda Khatick Road

Kolkata
WEST BENGAL
700046
India 
Phone  08617706696  
Fax    
Email  dasshreyasi05@gmail.com  
 
Source of Monetary or Material Support  
D N De Homoeopathic Medical College and Hospital, 12 Gobinda Khatick Road Kolkata 700046 
 
Primary Sponsor  
Name  D N De Homoeopathic Medical College and Hospital 
Address  12 Gobinda Khatick Road Kolkata 700046 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajat Kumar Pal  D N De Homoeopathic Medical College and Hospital  Reperory OPD no PG3, Surgery OPD no 5, Skin OPD no 5
Kolkata
WEST BENGAL 		 09433130996

drrajatkumarpal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of D. N. De Homoeopathic Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L030||Cellulitis and acute lymphangitisof finger and toe,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dioscorea villosa and concomitant care  Intervention is planned as administering Dioscorea villosa 30CH 4 doses a day for 2 days. Dioscorea villosa 200CH will be administered if symptom similarity is more; twice daily for one day, followed by another dose the next day. Dioscorea villosa 1000CH single dose will be administered. Each dose will consist of 4 cane sugar globules. 40 moistened with Dioscorea villosa, to be taken orally on a clean tongue with an empty stomach. The medicines and sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. Route of administration: per oral. Duration of therapy: 21 days. 
Comparator Agent  Identical-looking placebo and concomitant care  This group will receive placebos, identical in appearance to the verum. Each dose will consist of 4 cane sugar globules. 40 moistened with 90% v/v ethanol, to be taken orally on a clean tongue with an empty stomach. All sundry items will be procured from a GMP-certified firm. Concomitant care includes warm soaks for 10–15 minutes, several times daily. Route of administration: per oral. Duration of therapy: 21 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Age between 18 and 65 years.
2. Patients suffering from Acute paronychia [ICD-11 code: EE13.0]
3. Any one of the following symptoms of sufficient magnitude should be present as listed below:
a. Pain is sharp and agonizing when pricking is first felt.
b. Nails are brittle.
c. Pain spread, especially from the abdomen to distant parts.
d. Any symptoms better by stretching out and moving about.

 
 
ExclusionCriteria 
Details  1.Patient is denying consent to participate.
2.Patients with paronychia requiring surgical intervention at baseline.
3.Patients with a history of contact dermatitis from steroids, onychomycosis, psoriasis, lichen planus, or recent steroid/antibiotic treatment for paronychia.
4.Patients agreed not to use any other topical products.
5.Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure.
6.Pregnant and puerperal women, lactating mothers.
7.Vulnerable population – unconscious, non-ambulatory, too sick for consultation, differently abled, terminally or critically ill patients, institutionalized subjects, mentally incompetent people.
8.Habit of tobacco chewing, smoking, and other forms (s) of substance abuse and/or dependence.
9.Self-reported immune-compromised state.
10.Already undergoing homeopathic treatment for chronic disease for the last 2 weeks.
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Numerical Rating Scale (NRS)  Baseline, 1st, 2nd, 5th, 7th, 14th and 21st day. 
 
Secondary Outcome  
Outcome  TimePoints 
NAIL-Q  Baseline, 7th day, 14th and 21st day. 
 
Target Sample Size   Total Sample Size="108"
Sample Size from India="108" 
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)   01/02/2026 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drrajatkumarpal@gmail.com].

  6. For how long will this data be available start date provided 01-06-2027 and end date provided 31-05-2032?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Acute hand infections, often due to puncture wounds, are classified as superficial involving skin and subcutaneous tissues or deep involving deeper structures (tendon sheaths, fascial planes, joints, or bone), with superficial types being more common, and paronychia is one of the most frequent forms, arising from disruption of the protective barrier between the nail and surrounding tissue, occurring spontaneously or after trauma, and may affect a single nail or multiple nails if drug-induced. This outlines a double-blind, randomized (2:1), placebo-controlled clinical trial evaluating individualized Dioscorea villosa in adults with acute paronychia, with 108 participants recruited from a homoeopathic medical college skin and surgery OPD. The primary outcome is time to resolution of pain over 21 days measured by the Numerical Rating Scale, measured at baseline and subsequently on the 1st, 2nd, 5th, 7th, 14th and 21st day with secondary assessment of nail-related quality of life using the NAIL-Q, measured at baseline, 7th, 14th and 21st day. Comparative analysis will be carried out to detect group differences. Result will be published in scientific journals.   
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