| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L709||Acne, unspecified. Ayurveda Condition: KSHUDRAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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: - |
|
|
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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
|
|
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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 |