| CTRI Number |
CTRI/2022/07/043934 [Registered on: 12/07/2022] Trial Registered Prospectively |
| Last Modified On: |
02/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ayurvedic Management of Atopic Dermatitis -A Clinical Study |
|
Scientific Title of Study
|
A Randomized Open-Label Controlled Clinical Study to Evaluate The Efficacy Of Navakarshika guggulu In The Management Of Vicharchika With Special Reference to Atopic Dermatitis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mandre Jyothirmai |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College of Ayurveda Science and Research |
| Address |
Room number 304
Department of PG Studies in
Kayachikitsa
Sri Sri College of Ayurveda Science and Research
21st KM Kanakapura Road Udayapura Post Bangalore
Bangalore Rural
KARNATAKA
560082
India |
| Phone |
9900992845 |
| Fax |
|
| Email |
jyothirmaimandre9900@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sowmyashree U P |
| Designation |
Associate Professor |
| Affiliation |
Sri Sri College of Ayurveda Science and Research |
| Address |
Room number 304
Department of PG Studies in
Kayachikitsa
Sri Sri College of Ayurveda Science and Research
21st KM Kanakapura Road Udayapura Post Bangalore
Bangalore Rural
KARNATAKA
560082
India |
| Phone |
9743893056 |
| Fax |
|
| Email |
upsprasad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mandre Jyothirmai |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College of Ayurveda Science and Research |
| Address |
Room number 304
Department of PG Studies in
Kayachikitsa
Sri Sri College of Ayurveda Science and Research
21st KM Kanakapura Road Udayapura Post Bangalore
Bangalore Rural
KARNATAKA
560082
India |
| Phone |
9900992845 |
| Fax |
|
| Email |
jyothirmaimandre9900@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College of Ayurveda Science and Research |
|
|
Primary Sponsor
|
| Name |
Dr Mandre Jyothirmai |
| Address |
Room number 304
Department of PG Studies in
Kayachikitsa
Sri Sri College of Ayurveda Science and Research
21st KM Kanakapura Road Udayapura Post Bangalore
|
| Type of Sponsor |
Other [Self] |
|
|
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 Mandre Jyothirmai |
Sri Sri College of Ayurveda Science and Research |
Room number 304
Department of PG Studies in
Kayachikitsa
Sri Sri College of Ayurveda Science and Research
21st KM Kanakapura Road Udayapura Post Bangalore
Bangalore Rural
KARNATAKA |
9900992845
jyothirmaimandre9900@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI SRI INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L209||Atopic dermatitis, unspecified. Ayurveda Condition: VICHARCHIKA (ATOPIC DERMATITIS), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: NAVAKARSHIKA GUGGULU, Reference: YOGARATNAKARA BHAGANDHARA CHIKITSA, Route: Oral, Dosage Form: Guggulu , Dose: 2(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: LUKEWARM WATER), Additional Information: POLYHERBAL FORMULATION CONTAINING 5 INGREDIENTS PIPPALI HARITAKI VIBHITAKI AMALAKI SHUDDA GUGGULU
DOSAGE 2TABLETS (500MG) TWICE DAILY AFTERFOOD WITH LUKE WARM WATER FOR 1MONTH | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: NIMBADI YOGA , Reference: BHAISHAJYA RATNAVALI KUSHTAROGADHIKARA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 100(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: LUKE WARM WATER), Additional Information: -POLYHERBAL FORMULATION CONTAING 2 INGREDIENTS NIMBA TWAK AND ABHAYA PHALA DOSAGE OF 100MG/KG BODY WEIGHT TWICE DAILY AFTERFOOD WITH LUKEWARM WATER FOR 1MONTH |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Subjects who fulfill the diagnostic Criteria of Vicharchika with special reference to Atopic dermatitis
2 Subjects willing to participate with written informed consent, which is conveyed in the language which the subject can understand |
|
| ExclusionCriteria |
| Details |
1 Pregnant and Lactating Women
2 Subject With Any Uncontrolled systemic illness including Diabetes Mellitus, Hypertension.
3 Other dermatological diseases like seborrheic dermatitis, contact dermatitis and any other condition interfering with the course of disease and treatment. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Changes in signs and symptoms of Atopic dermatits
Erythema oozing excoriation dryness pruritis
|
15Th Day,30Th Day,45Th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1 Changes in SCORAD Index |
15Th Day,30Th Day,45Th Day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
15/07/2022 |
| 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="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
|
This Study is put Forward to Evaluate The Efficacy of Navakarshika guggulu in the Management of Vicharchika With Special Reference to Atopic Dermatitis in Comparision With Nimbadi yoga
Hypothesis Null Hypothesis (H0) The Efficacy of Navakarshika guggulu is Equivalent to Nimbadi yoga in The Management of Vicharchika with special Reference to Atopic Dermatitis Alternative Hypothesis (H1) The Efficacy of Navakarshika guggulu is Different From Nimbadi yoga in The Management of Vicharchika with special Reference to Atopic Dermatitis |