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CTRI Number  CTRI/2025/10/096597 [Registered on: 29/10/2025] Trial Registered Prospectively
Last Modified On: 28/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Other 
Public Title of Study   Study on Shami (Prosopis cineraria) Leaves, Stem Bark, and Root Bark for Treating Dadru (fungal infection) in 120 patients. 
Scientific Title of Study   Pharmaco-therapeutic Evaluation of Different Parts (Leaf, Stem Bark, and Root Bark) of Shami (Prosopis cineraria (L.) Druce) in the Management of Dadru w.s.r. to Dermatophytosis. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Vipan kumar saraswat 
Designation  Ph.D. scholar 
Affiliation  National Institute of Ayurveda 
Address  Department of Dravyaguna,National Institute of Ayurveda Jorawar Singh Gate, Amer Road JAIPUR - 302002 (RAJ.) INDIA

Jaipur
RAJASTHAN
302002
India 
Phone  8279934993  
Fax    
Email  vipan.sar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Tarun Sharma 
Designation  Assistant proffesor 
Affiliation  National Institute of Ayurveda 
Address  Department of Dravyaguna, National Institute of Ayurveda Jorawar Singh Gate, Amer Road JAIPUR - 302002 (RAJ.) INDI

Jaipur
RAJASTHAN
302002
India 
Phone  9887701733  
Fax    
Email  tarun.dg@nia.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Tarun Sharma 
Designation  Assistant proffesor 
Affiliation  National Institute of Ayurveda 
Address  Department of Dravyaguna, National Institute of Ayurveda Jorawar Singh Gate, Amer Road JAIPUR - 302002 (RAJ.) INDI

Jaipur
RAJASTHAN
302002
India 
Phone  9887701733  
Fax    
Email  tarun.dg@nia.edu.in  
 
Source of Monetary or Material Support  
National Institute of Ayurveda 
 
Primary Sponsor  
Name  national institute of ayurveda 
Address  National Institute of Ayurveda Jorawar Singh Gate, Amer Road JAIPUR - 302002 (RAJ.) INDIA 
Type of Sponsor  Government medical college 
 
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 
Vipan kumar saraswat  National Institute of Ayurveda  Opd no 19 Department of Dravyaguna,National Institute of Ayurveda Jorawar Singh Gate, Amer Road JAIPUR - 302002 (RAJ.) INDIA
Jaipur
RAJASTHAN 		 08279934993

vipan.sar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee National Institute of Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L299||Pruritus, unspecified. Ayurveda Condition: DADRU-KUSHTHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Stem bark of shami, Reference: Bhavprakash, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Dose as par area involved
2Comparator ArmDrugClassical(1) Medicine Name: Root bark of Shami, Reference: Bhavaprakasha, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Dose as per effected body area involved
3Comparator ArmDrugClassical(1) Medicine Name: Leaf of Shami, Reference: Bhavaprakasha, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Dose as per effected body area involved
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient with clinical sign and symptoms of Dadru with kandu,raga,pidaka and utsanna mandala.
Patients willing to give informed consent and adhere to the study protocol.The patient falls into the mild to moderate category based on body surface area (BSA) involvement, which ranges from 0% to 10%.
 
 
ExclusionCriteria 
Details  1. The patients suffering from severe systemic disorders.
2. The pregnant women and lactating mother will be excluded.
3. Known case of skin malignancy.
4. The patient falls into the severe category based on body surface area (BSA) involvement, which is greater than 10%
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary Outcome -Change in Final Severity Score based on Dermatophytosis Area and Severity Index  Primary Endpoint: Improvement in the Final Severity Score based on Dermatophytosis Area and Severity Index from baseline to the fourth weeks of the study. 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary Outcome -Change in the score of dermatology life quality index (DLQI).   Secondary Endpoint: Improvement in the Dermatology Life Quality Index (DLQI) from baseline to the fourth weeks of the study. 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   10/11/2025 
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="2"
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  

The study entitled Pharmaco-therapeutic Evaluation of Different Parts (Leaf, Stem Bark and Root Bark) of Shami in the Management of Dadru focuses on exploring the therapeutic role of Shami in Dadru. In Ayurveda, Dadru is described as a Kshudra Kushtha, predominantly involving Pitta Kapha dosha with symptoms such as circular patches, itching, redness, and eruptions. Clinically, it corresponds to superficial fungal infections, largely caused by Trichophyton rubrum. Conventional antifungal therapies often face challenges such as recurrence and resistance, highlighting the need for safe, affordable, and effective alternatives.   Shami has been traditionally used for skin diseases and possesses antifungal potential, with prior in vitro studies suggesting activity against Trichophyton rubrum and Candida albicans. This research will undertake pharmacognostical, phytochemical, and MIC analyses of Shami’s leaf, root bark, and stem bark, followed by a randomized, single-blind, three arm clinical trial involving 120 patients. Topical creams of 20 percent extracts will be prepared and assessed based on the Dermatophytosis Area and Severity Index, clinical symptom scoring, and Dermatology Life Quality Index. The study aims to compare and establish the relative efficacy of different parts of Shami, thereby contributing evidence-based validation for its role in the management of Dadru. 

 

 
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