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CTRI Number  CTRI/2025/02/080068 [Registered on: 07/02/2025] Trial Registered Prospectively
Last Modified On: 18/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A Study to understand the Effect of Katukichurna Internally and Mukhadhooshikaharalepa Externally in management of Acne 
Scientific Title of Study   Clnical Study to Evaluate the Efficacy of Bhedana with Katuki Followed by Mukhadhooshikaharalepa in Acne. 
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 Arjun Chand C P 
Designation  Associate Professor 
Affiliation  Pankajakasthuri Ayurveda Medical College & Pg Centre Killi Kattakada Thiruvananthapuram 
Address  Department of Kayachikitsa Room no: CO 06 Pankajakasthuri Ayurveda Medical College & PG Centre Killi kattakada Thiruvananthapuram

Thiruvananthapuram
KERALA
695572
India 
Phone  8072948368  
Fax    
Email  arjunchandcp@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Akhil J 
Designation  Post Graduate scholar 
Affiliation  Pankajakasthuri Ayurveda medical college & PG Centre Killi kattakada Thiruvananthapuram 
Address  Department of Kayachikitsa Room no: CO 05 Pankajakasthuri Ayurveda medical college & PG Centre Killi kattakada Thiruvananthapuram

Thiruvananthapuram
KERALA
695572
India 
Phone  9108845017  
Fax    
Email  akhilnirmala007@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Akhil J 
Designation  Post Graduate scholar 
Affiliation  Pankajakasthuri Ayurveda medical college & PG Centre Killi kattakada Thiruvananthapuram 
Address  Department of Kayachikitsa Room no: CO 06 Pankajakasthuri Ayurveda medical college & PG Centre Killi kattakada Thiruvananthapuram

Thiruvananthapuram
KERALA
695572
India 
Phone  9108845017  
Fax    
Email  akhilnirmala007@gmail.com  
 
Source of Monetary or Material Support  
Pankajakasthuri Ayurveda medical college & PG Centre Killi kattakada Thiruvananthapuram Kerala 695572 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [] 
 
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 Akhil J  Pankajakasthuri Ayurveda Medical College Hospital Kattakada  Op Kayachikitsa Department Room No:H 06 Pankajakasthuri Ayurveda Medical College Hospital Kattakada Thiruvananthapuram Kerala
Thiruvananthapuram
KERALA 
09108845017

akhilnirmala007@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee (IEC) Pankajakasthuri Ayurveda Medical College & PG Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L709||Acne, unspecified. Ayurveda Condition: KSHUDRAROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: MUKHADOOSHIKAHARALEPA, Reference: Kshudraroga Chikitsa Adhyaya of Sushrutha Samhitha , Route: Topical, Dosage Form: Lepa Churna, Dose: 100(g), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: -
(2) Medicine Name: KATUKI CHURNA, Reference: Deepanapachanadi kathanam of Sharangadhara Samhitha, Route: Topical, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Days, anupAna/sahapAna: Yes(details: WARM WATER), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  i. Subjects of age group 18-40 years irrespective of their gender and socio-economic status.

ii. Subjects selected using Clinical diagnosis of Acne based on ICD 10 L70.9 of Inflammatory Papules, pustules, Nodules. Non-inflammatory-Open and closed Comedones.

iii. Subjects with recurrent Acne since one month.

iv. Subjects willing to provide written informed consent.
 
 
ExclusionCriteria 
Details  i. Subjects with Acne induced due to androgenic steroids, anti-convalescents, Corticosteroids, Anti-epileptics, Antidepressants, Rifampicin, Isoniazid. will be excluded from the study.

ii. Subjects with skin issues other than Acne.

iii. Subjects with active phase of Diabetic carbuncles, Chickenpox.

iv. Subjects who are contraindicated for Virechana

v. Pregnant ladies and lactating mother
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Understanding Youvanapidaka in modern perspective.

To evaluate the effectiveness of Bhedana with Katuki followed by Mukhadooshikahara Lepa in the management of Acne.

1.Global Acne Grading System (GAGS).
2.Plewig And Kligmann Acne Assessment Scale.
3.Blood routine with Erythrocyte Sedimentation Rate
4.Random Blood Sugar
5.Absolute Eosinophil count
6.Renal Function test
7.Liver Function test
8.Contact Allergy Test
 

Assessment will be done on the 0th, 8th, 15th and 30th day

 
 
Secondary Outcome  
Outcome  TimePoints 
NOT APPLICABLE  NOT APPLICABLE 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
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)   17/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  17/02/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
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 - NO
Brief Summary
Modification(s)  

CLINICAL STUDY TO EVALUATE THE EFFICACY OF BHEDANA WITH KATUKI FOLLOWED BY MUKHADHOOSHIKAHARA LEPA IN ACNE.

 

 Akhil J1, Dr Arjun Chand2, Dr Aparna Chandran3

Acne, a common skin condition, manifests as various types of blemishes on the skin, predominantly occurring during adolescence but can persist into adulthood for some individuals. It typically arises when hair follicles become clogged with oil and dead skin cells, leading to the formation of pimples, blackheads, whiteheads, or cysts. The primary culprit behind acne development is often an overproduction of sebum, an oily substance produced by the skin’s sebaceous glands. This excess oil, combined with bacteria and dead skin cells, creates an ideal environment for inflammation and the subsequent appearance of acne lesions.

Youvanapidaka, refers to a specific type of skin condition characterized by the formation of stubborn, deepseated pimples or boils on the face. These eruptions are often painful and can leave behind scars if not properly managed. It’s one among the Kshudrarogas told by Acharya Sushrutha in Kshudraroga Pratisheda on Sushrutha Samhitha. Youvanapidaka is primarily caused by an imbalance in the body’s doshas, specifically the aggravation of Pitta and Kapha doshas. Pitta, responsible for digestion and metabolism when disturbed, leads to the accumulation of toxins (ama) in the body, which manifest as skin issues like Youvanapidaka. Kapha imbalance contributes to excess oil production and blockage of skin pores, further exacerbating the condition. Further Dosha dooshya sammurchana in the Raktavahasrotas of face which leads to Pidaka Utpatti is the main pathology. Such a condition needed to be managed with Laghu, Rooksha, Tikshna, Kaphapitta shamaka, Twachya and Krimihara Dravya. Hence the formulation named Mukhadooshikahara Lepa with above mentioned qualities is selected for the study.

This study is proposed as Interventional clinical study with pre and post-test. Subjects   irrespective of gender at the age group of 18-40 years registered in the OP Department of Kayachikitsa, Pankajakasthuri Ayurveda Medical College Hospital, Kattakada, Thiruvananthapuram, satisfying the inclusion criteria will be selected for the study. Subjects will be consecutively selected into the study till attaining the sample size of 35. The necessary data will be collected through observation, examination and history taking. Then the data will be recorded using case record form. 

Subjects will be advised Katuki Churna 2g with warm water on the 0th day night bed time and from the next day Mukhadooshikahara Lepa mixed with water is to be applied externally over acne in 3mm thickness for 14 days. Assessment will be done on 0thday, 8th day, 15thday and 30th day using objective parameters. Changes will be compared using Plewig and Kligmann Acne Assessment scale. The results will be analyzed statistically and conclusions will be drawn 
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