| CTRI Number |
CTRI/2023/09/057620 [Registered on: 14/09/2023] Trial Registered Prospectively |
| Last Modified On: |
25/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
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Public Title of Study
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This Clinical Trial is intented to compare the efficacy of Mukhadushikahara Acne Patch with Mukhadushikahara lepa along with Triphaladi Kashaya intenally in the management of Acne Vulgaris. |
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Scientific Title of Study
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Critical Study of Tistraishaniya Adhyaya of Charaka Samhita w.s.r. to Bahiparimarjana Chikitsa and Comparative Clinical Efficacy of Mukhadushikahara Acne Patch and Mukhadushikahara Lepa along with Triphaladi Kashaya in the management of Mukhadushika (Acne Vulgaris)
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| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rananavare Dipa Shivaji |
| Designation |
PhD Scholar, Institute of Teaching and Research in Ayurveda, Jamnagar |
| Affiliation |
Institute of Teaching and Research in Ayurveda, Jamnagar |
| Address |
Department of Basic Principles,
Opd No 11,
Institute of Teaching and Research in Ayurveda,
B division Police station,
Near Gujarat Ayurved University,
Opposite to Reliance Smart,
Jamnagar.
Jamnagar
GUJARAT
361008
India |
| Phone |
9764271613 |
| Fax |
|
| Email |
dsrananavare333@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shubhangi Kamble |
| Designation |
Associate Professor, Dept. of Basic Principles, ITRA, Jamnagar |
| Affiliation |
ITRA, Jamnagar |
| Address |
Department of Basic Principles,
Opd No 11,
Institute of Teaching and Research in Ayurveda,
B division Police station,
Near Gujarat Ayurved University,
Opposite to Reliance Smart,
Jamnagar.
Jamnagar
GUJARAT
361008
India |
| Phone |
9428400109 |
| Fax |
|
| Email |
shubhangikamble@itra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubhangi Kamble |
| Designation |
Associate Professor, Dept. of Basic Principles, ITRA, Jamnagar |
| Affiliation |
ITRA, Jamnagar |
| Address |
Department of Basic Principles,
Opd No 11,
Institute of Teaching and Research in Ayurveda,
B division Police station,
Near Gujarat Ayurved University,
Opposite to Reliance Smart,
Jamnagar.
Jamnagar
GUJARAT
361008
India |
| Phone |
9428400109 |
| Fax |
|
| Email |
shubhangikamble@itra.edu.in |
|
|
Source of Monetary or Material Support
|
| Institute of Teaching and Research in Ayurveda, Jamnagar 361008 |
|
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Primary Sponsor
|
| Name |
Institute of Teaching and Research in Ayurveda, Jamnagar |
| Address |
Institute of Teaching and Research in Ayurveda,
B division Police station,
Near Gujarat Ayurved University,
Opposite to Reliance Smart,
Jamnagar.
B division Police station
Near Gujarat Ayurved University
Opposite to Reliance Smart
Jamnagar |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shubhangi Kamble |
Institute of Teaching and Research in Ayurveda Hospital |
Department of Basic Principles,
Opd No 11,
Institute of Teaching and Research in Ayurveda,
B division Police station,
Near Gujarat Ayurved University,
Opposite to Reliance Smart,
Jamnagar.
Jamnagar
GUJARAT |
9428400109
shubhangikamble@itra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Institute of Teaching and Research in Ayurveda, Jamnagar, Gujarat. |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L700||Acne vulgaris. Ayurveda Condition: YUVANAPIDAKAÂ (MUKHADUSHIKA), (2) ICD-10 Condition:L449||Papulosquamous disorder, unspecified. Ayurveda Condition: YUVANAPIDAKAÂ (MUKHADUSHIKA), (3) ICD-10 Condition:L449||Papulosquamous disorder, unspecified. Ayurveda Condition: YUVANAPIDAKAÂ (MUKHADUSHIKA), (4) ICD-10 Condition:L55-L59||Radiation-related disorders of the skin and subcutaneous tissue. Ayurveda Condition: KSHUDRAROGAH yuvanpidika, |
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Intervention / Comparator Agent
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| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Mukhadushikahara Lepa, Reference: Sushruta Chikitsa 20/38, Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Mukhadushikahara Lepa will be applied topically with conventional method.(2) Medicine Name: Triphaladi Kashaya, Reference: Charak Chikitsa 7/100, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Triphaladi Kashaya will be administered internally along with topical Mukhadushikahara Lepa. | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Mukhadushikahara Acne Patch, Reference: Sushruta Chikitsa 20/38, Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Mukjadushikahara Acne Patch will be prepared using these classical herbs and will be used topically(2) Medicine Name: Triphaladi Kashaya, Reference: Charak Chikitsa 7/100, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Triphaladi Kashaya will be administered internally along with Topical Mukhadushikahara Acne Patch. |
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Patients having classical signs and symptoms of Mukhadushika (Acne Vulgaris) on Face. |
|
| ExclusionCriteria |
| Details |
1. The age of patient less than 18 years and more than 30 years.
2. Patients having Mukhadushika on other parts of body.
3. Known cases of any systemic diseases like Diabetes, Cardiac diseases, Renal disorder, Hypothyroidism etc. or any viral infection.
Known cases of Carcinogenic condition of sebaceous gland.
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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On-site computer system |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
Relief in the Chief Complaints of Mukhadushika (Acne Vulgaris)-Number of Pidaka (papules), Ruja (pain), Ghana pidaka (thickness), Daha (burning sensation), Srava (discharge), Medogarbha (filled with sebum) will be assessed. Number of lesions (papules/ pustules / nodular) & Area cover will be measured before and after treatment.
Severity of Acne Vulgaris will be assessed using (IGAS scale) before and after treatment. |
Baseline, 7th Day. 15th Day, 21st Day, 30th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Relief in the Associated Complaints of Mukhadushika (Acne Vulgaris) viz. Shotha (Inflammation), Kandu (Itching), Snigdha Tvaka (Oily skin), Vrana Vastu (Scar), Vaivarnya (Discolouration), Shotha (Inflammation) will be assessed.
|
Baseline, 7th Day, 14th Day,21st Day, 30th Day. |
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Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/11/2023 |
| 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) |
Open to Recruitment |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
An open labelled, randomized, comparative, parallel, two arm clinical trial has been designed for comparison of efficacy of topical application of Mukhadushikahara Acne Patch and Mukhadushikahara Lepa along with Triphaladi Kashaya as internal medicine in the management of Mukhadushika (Acne Vulgaris) for 30 days. There will be two groups with sample size 50 in either group. Primary outcome will be relief in the Chief Complaints of Mukhadushika (Acne Vulgaris) viz. Number of Pidaka (papules), Ruja (pain), Ghana pidaka (thickness), Daha (burning sensation), Srava (discharge), Medogarbha (filled with sebum). Secondary outcome will be Relief in the Associated Complaints of Mukhadushika (Acne Vulgaris) viz. Shotha (Inflammation), Kandu (Itching), Snigdha Tvaka (Oily skin), Vrana Vastu (Scar), Vaivarnya (Discolouration), Shotha (Inflammation).
In group A - Mukhadushikahara Acne Patch (external) along with Triphaladi Kashaya as internal medicine will be given for 30 days. In group B- Mukhadushikahara Lepa along with Triphaladi Kashaya as internal medicine will be given for 30 days.
Materials: 1. Patients of Mukhadushika (Acne vulgaris).
2. Trial drugs – Triphaladi Kashaya, Mukhadushikahara lepa, Mukhadushikahara Acne Patch.
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