| CTRI Number |
CTRI/2023/04/051362 [Registered on: 06/04/2023] Trial Registered Prospectively |
| Last Modified On: |
05/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Efficacy of certain Ayurvedic formulations in the management of Acne |
|
Scientific Title of Study
|
Clinical Evaluation of Nimbadi Churna, Khadirarishta and Arjuna lepa in the management of Yuvan Pidika (Acne) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suprabha K |
| Designation |
Research Officer (Ayurveda) |
| Affiliation |
Regional Ayurveda Research Institute Ahmedabad CCRAS Ministry of Ayush Government of India |
| Address |
Regional Ayurveda Research Institute Ahmedabad
Block A and D 2nd floor Bahumali bhavan Manjushree Mill compound Near Girdharnagar over bridge Asarwa Ahmedabad 380004
Ahmadabad
GUJARAT
380004
India |
| Phone |
9164387950 |
| Fax |
|
| Email |
suprabha.k@ccras.nic.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suprabha K |
| Designation |
Research Officer (Ayurveda) |
| Affiliation |
Regional Ayurveda Research Institute Ahmedabad CCRAS Ministry of Ayush Government of India |
| Address |
Regional Ayurveda Research Institute Ahmedabad
Block A and D 2nd floor Bahumali bhavan Manjushree Mill compound Near Girdharnagar over bridge Asarwa Ahmedabad 380004
Ahmadabad
GUJARAT
380004
India |
| Phone |
9164387950 |
| Fax |
|
| Email |
suprabha.k@ccras.nic.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suprabha K |
| Designation |
Research Officer (Ayurveda) |
| Affiliation |
Regional Ayurveda Research Institute Ahmedabad CCRAS Ministry of Ayush Government of India |
| Address |
Regional Ayurveda Research Institute Ahmedabad
Block A and D 2nd floor Bahumali bhavan Manjushree Mill compound Near Girdharnagar over bridge Asarwa Ahmedabad 380004
Ahmadabad
GUJARAT
380004
India |
| Phone |
9164387950 |
| Fax |
|
| Email |
suprabha.k@ccras.nic.in |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Ayurvedic Sciences
|
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Ayurvedic Sciences |
| Address |
61-65, opp. D Block, Institutional Area, Janakpuri, New Delhi, Delhi
110058 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr P Srinivas |
Dr A Lakshmipathi Regional Ayurveda Research Institute, Chennai |
OPD Section VHS Hospital Campus Taramani
Chennai 600113
Chennai
TAMIL NADU |
9840879433
drsrinivaspitta@gmail.com |
| Dr K Midhuna Mohan |
Regional Ayurveda Research Institute Vijayawada |
OPD block New Rajiv Nagar Payakapuram
Vijayawada 520 015
Krishna
ANDHRA PRADESH |
8639006068
midhunamohan@gmail.com |
| Dr Suprabha K |
Regional Ayurveda Research institute, Ahmedabad |
OPD section Block A and D 2nd floor Bahumali bhavan Manjushree Mill compound Near Girdharnagar over bridge Asarwa Ahmedabad 380004
Ahmadabad
GUJARAT |
9164387950
suprabha.k@ccras.nic.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - Regional Ayurveda Research Institute Ahmedabad |
Approved |
| Institutional Ethics Committee - Regional Ayurveda Research Institute Vijayawada |
Approved |
| Institutional Ethics Committee-Dr A Lakshmipathi Regional Ayurveda Research Institute, Chennai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L709||Acne, unspecified. Ayurveda Condition: YUVANAPIDAKAÂ (MUKHADUSHIKA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Nimbadichurna, Reference: API-Part II, Vol I, Pg-51; AFI- Part-I, Pg-112; Bh. Rt. Vataraktadhikar-31/33, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: water), Additional Information: -(2) Medicine Name: Khadirarishta, Reference: API, Part-II, Vol-II, Pg-33; AFI, Part I, 1:14, Route: Oral, Dosage Form: Arishta, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: water), Additional Information: -(3) Medicine Name: Arjuna lepa, Reference: R. Kshudraroga chikitsa-3, pg-739, Route: Topical, Dosage Form: Lepa Churna, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: No, Additional Information: Local application of the paste of Arjuna lepa |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of either sex with age between 18 and 45 year
2.Patients with acne inflammatory lesion (Papules and Pustules) count less than twenty, non-inflammatory lesion (open and closed comedones) count less than fifty and nodules less than four
3.Willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
1. Patients with Secondary acne and severe acne viz. acne fulminans, acne conglobate, acne excoriate.
2. Patient with the presence of cysts.
3. Patient taking any topical or systemic treatment for acne for last 2 weeks.
4. Patients with cosmetic induced acne.
5. Patients pregnant or lactating or in menopause or taking oral contraceptives.
6. Patients with polycystic ovarian syndrome or undergoing treatment for infertility.
7. Dermal sensitivity to light, generalized skin lesions, eczema, psoriasis, herpes simplex, herpes zoster, scabies, urticaria, and immunological medicated skin diseases like pempigus vulgaris, dermatitis, lupus erythematous, psoriatic arthropathy etc.
8. Immuno-compromised states and patients with systemic infections orknown cases of AIDS, HIV, STD etc.
9. Patients with severe/history of cardiac, hepatic, cerebrovascular disease, pulmonary dysfunction, malignancy, chronic uncontrolled systemic diseases or renal disorder ( S. creatinine >1.2 mg/dl) etc or poorly controlled hypertension (Blood pressure more than 160/100mm of Hg), uncontrolled Diabetes Mellitus (HbA1c ≥ 8), or any other serious medical illness.
10. Patients on medication with corticosteroids or any other drugs that may have an influence on the outcome of the study.
11. History of hypersensitivity to the trial drug or any of its ingredients.
12. Patients with facial beard or mustache that could interfere with the study assessments.
13. Patients who have completed participation in any other clinical trial during the past three months.
14. Any other condition which the Investigator thinks may jeopardize the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome measure
Change in Global Acne Grading System score
Change in Investigators Global Assessment IGA scale score
|
at baseline, 15th day, 30th day, 45th day, 60th day, 75th day, 90th day and 105th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in the Ayurvedic parameters of Yuvan Pidika
Change in Dermatology Life Quality Index (DLQI) Questionnaire
Change in The Cardiff Acne Disability Index
Change in Patient Satisfaction (PS) Scoring
|
at baseline, 15th day, 30th day, 45th day, 60th day, 75th day, 90th day and 105th day |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
20/04/2023 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The present study aims to
evaluate the efficacy of Nimbadichurna, Arjuna Lepa, and Khadirarishta
in treating mild to moderate acne. It is an open-label single-arm prospective interventional study involving 40 participants in each center with a total of 120 participants. The total study duration is 24 months wherein acne patients
of either sex with age between 18 and 45 years are included in the Study. Intervention is for 12 weeks and the outcome is the improvement in the assessment parameters such as Global Acne Grading System, Investigators’ Global Assessment (IGA) scale, Assessment of Ayurvedic parameters of Yuvan Pidika, Dermatology life Quality Index (DLQI) Questionnaire, The Cardiff Acne Disability Index, and Patient Satisfaction (PS) Scoring. |