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CTRI Number  CTRI/2025/07/091055 [Registered on: 16/07/2025] Trial Registered Prospectively
Last Modified On: 10/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to evaluate the efficacy of shalmali kantaka and bala moola Powder application in pimples  
Scientific Title of Study   Pharmacognostical and Clinico-comparative Study to Evaluate the Efficacy Of Bala moola (Sida cordifolia Linn) and Shalmali (Bombax ceiba Linn) Kantaka lepa in Mukhadooshika . 
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 Pallavi  
Designation  PG Scholar  
Affiliation  N K Jabshetty Ayurvedic Medical College and PG center 
Address  N K Jabshetty Ayurvedic Medical College and PG center Bidar OPD NO 4 Kayachikitsa and OPD NO 5 Panchakarma Sri Siddharoodha charitable hospital bidar karnataka 585403 India
N K Jabshetty Ayurvedic Medical College and PG center Bidar OPD NO 4 Kayachikitsa and OPD NO 5 Panchakarma Sri Siddharoodha charitable hospital bidar karnataka 585403 India
Bidar
KARNATAKA
585403
India 
Phone  9019263377  
Fax    
Email  pallavibiradar16@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dhulappa M  
Designation  Professor and HOD  
Affiliation  N K Jabshetty Ayurvedic Medical College and PG center  
Address  N K Jabshetty Ayurvedic Medical College and PG center Bidar
Sri Siddharudh Charitable Hospital N K Jabshetty Ayurvedic Medical College and PG center Bidar
Bidar
KARNATAKA
585403
India 
Phone  9916268631  
Fax    
Email  dhulappam@gmail.com   
 
Details of Contact Person
Public Query  
Name  Dr Dhulappa M  
Designation  Professor and HOD  
Affiliation  N K Jabshetty Ayurvedic Medical College and PG center  
Address  N K Jabshetty Ayurvedic Medical College and PG center Bidar
Sri Siddharudh Charitable Hospital N K Jabshetty Ayurvedic Medical College and PG center Bidar
Bidar
KARNATAKA
585403
India 
Phone  9916268631  
Fax    
Email  dhulappam@gmail.com   
 
Source of Monetary or Material Support  
Sri Siddharudha Charitable Hospital N. K Jabshetty ayurvedic medical college and PG center Gumpa Bidar Karnataka India 585403 
 
Primary Sponsor  
Name  N K Jabshetty Ayurvedic Medical College and PG center Bidar  
Address  sri siddharoodha charitable hospital siddharoodha math manhalli road gumpa Bidar karnataka India 585403 
Type of Sponsor  Other [Self] 
 
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 Pallavi   Sri siddharoodha charitable hospital   OPD NO 5 Panchakarma OPD NO 4 Kayachikitsa of Sri siddharoodha charitable hospital N. K. Jabshetty Ayurvedic Medical college and PG center Bidar KARNATAKA
Bidar
KARNATAKA 		 9019263377

pallavibiradar16@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L700||Acne vulgaris. Ayurveda Condition: KSHUD,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Shalmali Kantaka, Reference: Sushruta Samhita , Route: Topical, Dosage Form: Kalka/ Paste , Dose: 0(NA), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Godugdha ), Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Bala Moola , Reference: Sushruta samhita , Route: Topical, Dosage Form: Kalka/ Paste , Dose: 0(NA), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Godugdha ), Additional Information: -
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1. Subjects in the age group between 12-30 yrs.
2.Subjects fulfilling the diagnostic criteria of Mukhadooshika will be randomly selected irrespective of gender, religion, and occupation. 
 
ExclusionCriteria 
Details  1. Subjects in the age group between 12-30 yrs.
2.Subjects fulfilling the diagnostic criteria of Mukhadooshika will be randomly selected irrespective of gender, religion, and occupation.
 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
By the Application of Shalmali Kantaka to the subjects of mukhadushika may be beneficial to reduce the number of pidaka and helps to enhance the colour and complexion in coparision with bala moola lepa.   21 Days and follow-up will be on 31st day  
 
Secondary Outcome  
Outcome  TimePoints 
Number of Pidaka (eruption)
Global Acne grading system. 		 21 Days  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   17/07/2025 
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="6"
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  

METHODS OF COLLECTION OF DATA:

Research Design

1.     Study Design: Pharmacognostical and open label, two-arm, randomized clinical trial.

2.     Sample Size: 30 subjects of Mukhadooshika.

3.     Selection Criteria: Diagnosed subjects of  Mukhadooshika will be selected on the basis of simple randomized sampling procedure by preparing special case proforma.

4.     Duration: 21 days.

5.     Time : Slight dry (10 -15 minutes)

6.     Thickness : Ardhangula (0.97cm)

7.     Grouping: 30 subjects will be allocated into two groups, consisting of 15 subjects in each group.

Trial Group 1- will be treated by using  Paste of  Bala moola churna with milk applied externally 1 time daily for 21 days

Control Group 11- will be treated by using  Paste of Shalmali kantaka churna with milk applied externally 1 time daily for 21days

FOLLOW UP:

Treatment duration will be 21 days for each group

Follow up after treatment- 10thday for each group

Total duration of study will be 31 days.

 

INCLUSION CRITERIA:

1. Subjects in the age group between 12-30 yrs.

2.Subjects fulfilling the diagnostic criteria of Mukhadooshika will be randomly selected irrespective of gender, religion, and occupation.

EXCLUSION CRITERIA:

1.Subjects aged less than 12 years and more than 30 years.

2. Subjects having other skin diseases like psoriasis, skin tuberculosis and other systemic diseases

3. History of allergy to topical applications.

 ASSESSMENT CRITERIA:

The subjective and objective parameters of base line data  during and after treatment will be compared for the assessment of the result.

PARAMETERS:

SUBJECTIVE  PARAMETERS:

Signs and Symptoms of Mukhadooshika as well as Acne Vulgaris explained in ayurvedic and modern texts respectively such as: Pidaka, vedana, medogranthi, comedones, papules, pustules, nodules will be taken into consideration

1)     Vedana (pain):

  

OBJECTIVE PARAMETERS:

 Number of Pidaka (eruption):

  Global Acne grading system.

Score of Pidaka on the basis of affected area.

LOCAL SCORE (F XS): After calculating local score for each location of the face, total of score will be done. Then on basis of Acne severity index, severity is calculated.

STATISTICAL ANALYSIS: Statistical evaluation of  above parameters will be carried

out by using Student’s ‘t’ test. i.e. Paired (within the group ) , Unpaired (between  the group).

 

 
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