| CTRI Number |
CTRI/2020/11/029384 [Registered on: 26/11/2020] Trial Registered Prospectively |
| Last Modified On: |
02/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Screening |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
EFFECT OF KHADIRARISHTA, KAISHORE GUGGULU AND
GANDHAKADI MALHAR IN THE VICHARCHIKA (ECZEMA)
|
|
Scientific Title of Study
|
CLINICAL EVALUATION OF KHADIRARISHTA, KAISHORE GUGGULU AND
GANDHAKADI MALHAR IN THE MANAGEMENT OF VICHARCHIKA (ECZEMA)
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
sujata dhoke |
| Designation |
Research officer Ayu |
| Affiliation |
Regional Ayurveda Research Institute for skin disorders |
| Address |
room no 10 clinical department 3rd floor Regional Ayurveda research institute for skin disorders new rajiv nagar payakapuram vijayawada
Krishna
ANDHRA PRADESH
520015
India |
| Phone |
9490334048 |
| Fax |
|
| Email |
sujubasic@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
sujata dhoke |
| Designation |
Research officer Ayu |
| Affiliation |
Regional Ayurveda Research Institute for skin disorders |
| Address |
room no 10 clinical department 3rd floor Regional Ayurveda research institute for skin disorders new rajiv nagar payakapuram vijayawada
Krishna
ANDHRA PRADESH
520015
India |
| Phone |
9490334048 |
| Fax |
|
| Email |
sujubasic@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Savita Gopod |
| Designation |
Research officer Ayu |
| Affiliation |
Regional Ayurveda Research Institute for skin disorders |
| Address |
room no 11 clinical department 3rd floor Regional Ayurveda research institute for skin disorders new rajiv nagar payakapuram vijayawada
Krishna
ANDHRA PRADESH
520015
India |
| Phone |
9177777631 |
| Fax |
|
| Email |
savitagopod18@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Ayurvedic sciences new Delhi |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Ayurvedic sciences |
| Address |
Jawaharlal Nehru Bharatiya Chikitsa Evam Homeopathy Anusandhan Bhawan 61-65 Institutional Area Opp D Black Janakapuri New 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 |
| Paikrao Sumed N |
room no 01 technical department Regional Ayurveda Research Institute for skin disorders |
Regional Ayurveda Research Institute for skin disorders block A and D second floor bhahumali bhavan Asarwa Ahmedabad
Ahmadabad
GUJARAT |
7698825705
sampaikrao27@gmail.com |
| sujata dhoke |
room no 10 technical department Regional Ayurveda Research Institute for skin disorders |
Regional Ayurveda Research Institute for skin disorders new rajiv nagar payakapuram vijayawada
Krishna
ANDHRA PRADESH |
9490334048
sujubasic@gmail.com |
| Dr S Asha |
Room no 11 Technical Department Dr Achanta Lakshmipathi Research Centre for Ayurveda |
Dr Achanta Lakshmipathi Research Centre for Ayurveda VHS campus TTTI Post Chennai
Chennai
TAMIL NADU |
9895192067
dr.ashas2324@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ALRCA Chennai |
Approved |
| Institutional Ethics Committee RARISD Ahmedabad |
Approved |
| Institutional Ethics Committee RARISD Vijayawada |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L209||Atopic dermatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Khadirarishta kaishor guggulu Gandhakadi Malahar |
Khadirarishta 30ml BD after meals for 12 weeks kaishor guggulu 1gm tid (500mg/pill) for 12 weeks with lukewarm water Gandhakadi Malahar 20 gm BD for External application for 12 weeks |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Known cases of eczema (based on Hanifin and Rajka Criteria for Atopic Dermatitis/ Atopic Eczema) and willing and able to participate in the study |
|
| ExclusionCriteria |
| Details |
Patients with Status Eczematous condition.
Patients with poorly controlled Hypertension ( >160/100 mmHg)
Patients with uncontrolled Diabetes Mellitus having HbA1C > 8%
Patients on medication with corticosteroids, phototherapy, biologics, antidepressants and any other drugs that may have an influence on the outcome of the study.
Patients who have history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months
Symptomatic patients with clinical evidence of Heart failure
Known cases of HIV and AIDS.
Known cases of malignancy
Patient taking participation in any other clinical trial.
Women who are planning for conception / pregnant or lactating.
Patients with concurrent serious hepatic disorders (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT) > 2 times upper normal limit) or Renal Disorders (defined as S. Creatinine >1.2mg/dL), Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease (COPD)
H/o hypersensitivity to any of the trial drugs or their ingredients
Patients who have completed participation in any other clinical trial during the past three months
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 |
| To evaluate the clinical efficacy of Khadirarishta, Kaishoreguggulu and Gandhakadimalaharin Vicharchika (Eczema) by the assessmentof Change in Eczema Area Severity Index score (EASI) |
14th day 28th day 42th day 56th day 70th day 84th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in clinical Sign & symptoms as per the Ayurvedic classics
Changes in Patient Oriented Eczema measure (POEM) Changes in Dermatology Life Quality Index (DLQI) Questionnaire
|
14th day 28th day 42th day 56th day 70th day 84th day |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
16/12/2020 |
| Date of Study Completion (India) |
20/09/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Results are not published yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Vicharchika is described under the Kshudra
Kushtha which is a chronic skin disorder. The general etiological factors are
intake of incompatible foods/drinks, suppression of natural urges like vomiting
etc., excess intake of fish, black gram, salty, sour and uncooked foods,
Exposure to heat immediately after taking food, indulging in sexual activity
even if the food is not well digested, sleeping during day time etc. In this
study, Khadirarishta, Kaishore guggulu internally and Gandhakadi Malahar
externally are taken up for clinical evaluation and outcome will be measured
by assessment of Change
in Eczema Area Severity Index score (EASI) and Changes in clinical
Sign & symptoms as per the Ayurvedic classics, Changes in Patient Oriented Eczema Measure (POEM) and Changes
in Dermatology Life Quality Index (DLQI) Questionnaire. |