| CTRI Number |
CTRI/2020/05/025030 [Registered on: 05/05/2020] Trial Registered Prospectively |
| Last Modified On: |
01/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
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Public Title of Study
|
Role of Ayurvedic drugs (Panchatikta Ghrita Guggulu, Guduchyadi Kwatha and Manjishthadi Taila) in the Management of Eczema. |
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Scientific Title of Study
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“A Randomized Comparative Clinical Study to Evaluate the Efficacy of Panchatikta Ghrita Guggulu, Guduchyadi Kwatha and Manjishthadi Taila in the Management of Vicharchika W.S.R. to Eczema.†|
| Trial Acronym |
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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 |
Bharti Panchal |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda, Jaipur |
| Address |
P.G. Department of Kayachikitsa
National Institute of Ayurveda, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8385081794 |
| Fax |
|
| Email |
bhartipanchaljpr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bharti Panchal |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda, Jaipur |
| Address |
P.G. Department of Kayachikitsa
National Institute of Ayurveda, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8385081794 |
| Fax |
|
| Email |
bhartipanchaljpr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bharti Panchal |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda, Jaipur |
| Address |
P.G. Department of Kayachikitsa
National Institute of Ayurveda, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8385081794 |
| Fax |
|
| Email |
bhartipanchaljpr@gmail.com |
|
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Source of Monetary or Material Support
|
| National Institute of Ayurveda, Jaipur (Raj.) |
|
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Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
Jaipur-302002, Rajasthan,India
|
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Hari Mohan Lal Meena |
National Institute of Ayurveda, Jaipur |
OPD Room No. 1, 7, 18, and 25 PG Department of kayachikitsa
Jaipur
RAJASTHAN |
9461297017
hari_mohan68@yahoo.co.in |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIA IEC |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L209||Atopic dermatitis, unspecified, |
|
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Comparator Agent |
Guduchyadi Kwatha’ and
Manjishthadi Taila’ |
25 patients will be administered trial drug Guduchyadi Kwatha 40 ml twice in a day orally , before meal in morning and evening along with Manjisthadi Taila twice in a day for local application on the lesion of the Eczema for the duration of 30 days. |
| Intervention |
Panchatikta Ghrita Gugglu and Manjishthadi Taila |
25 patients will be administered trial drug Panchatikta Ghrita Guggulu 500 mg twice in a day orally, before meal in morning and evening along with Manjisthadi Taila twice in a day for local application on the lesion of Eczema for the duration of 30 days. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients willing to participate in the clinical trial.
2. Patients age between 18-70 years.
3. Patients of both sex male and female.
4. The patients having clinical signs and symptoms of Vicharchika (Eczema).
5. The Patients having complain less than 5 years duration.
|
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| ExclusionCriteria |
| Details |
1. Patients below the age of 18 years and above 70 years.
2. Patients with Steroid and cytotoxic treatment.(>3 years)
3. Patients having concomitant illness like uncontrol HTN, uncontrol DM Type-2 and chronic Eczema.
4. Patients with evidence of malignancy.
5. Pregnant or lactating women.
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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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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
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Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
| Changes in the Bahusrava symptom of Vicharchika (Eczema). |
0th and 30th day |
|
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Secondary Outcome
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| Outcome |
TimePoints |
| Changes in the objective parameters. |
0th and 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 |
|
Date of First Enrollment (India)
|
07/05/2020 |
| 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 |
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Estimated Duration of Trial
|
Years="0"
Months="7"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
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NIL |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
|
Now days,Vicharchika has become one of the prime skin disease at general OPD level due to offensive diet habits,fast life style,industrial and occupational hazards,repeated use of chemical additives etc.Ayurveda has a lot to offer in this regard since time immemorial.Despite of great advance in dermatology and the advent of powerful antibiotics,antifungal,as well as steroids,eczema continues to defy the best effect of dermatologists, hence it is the need of the hour to find out safe and effective medicine for Vicharchika and here comes the role of Ayurveda. SELECTION OF DRUG :
In the present clinical trial focuses on the use of ‘Panchatikta Ghrita Guggulu’,‘Guduchyadi Kwatha’, for oral intake and ‘Manjishthad iTaila’for local application.‘Panchatikta Ghrita Gugglu’ is described in Bhaishyaja Ratnavali (Kushthachikitsa 54/233-236),‘Guduchyadi Kwatha’ is described in Bharat Bhaishajya Ratanakara part2(Kushthachikitsa1275) and ‘Manjishthadi Taila ’is described in vrindamadhava/siddhyoga(51/151)respectively.
‘Panchatikta Ghrita Guggulu’,‘Guduchyadi Kwatha’and‘Manjishthadi Taila’ may work as better effective drug for ‘Vicharchikia’. Above mentioned drugs are easily available, cost effective and easy to administrates. This is the basic reason to select these drugs for clinical trial.
AIMS & OBJECTIVES : 1. Clinical evaluation of the efficacy of ‘Panchatikta Ghrita Guggulu’,‘Guduchyadi Kwatha’and‘ManjishthadiTaila’ in the Management of Vicharchikaw.s.r. to Eczema. 2. Comparative study of efficacy between‘Panchatikta Ghrita Guggulu’&‘Manjishthadi Taila’ and‘Guduchyadi Kwatha’&‘Manjishthadi Taila’ in the Management of Vicharchikaw.s.r. to Eczema.
HYPOTHESIS :
• Null Hypothesis (Ho) : i. ‘Panchatikta Ghrita Guggulu’with‘Manjishthad iTaila’ and ‘Guduchyadi Kwatha’ with ‘Manjishthadi Taila’are equally effective in the management of VicharchikaW.S.R. to Eczema. • Alternative Hypothesis (HA) : i. ‘Panchatikta Ghrita Guggulu’with‘Manjishthadi Taila’ and ‘Guduchyadi Kwatha’ with ‘Manjishthadi Taila’are not equally effective in the management of VicharchikaW.S.R. to Eczema. Criteria of Assessment : ▪ QUALITATIVE VARIABLES : 1. Kandu (pruritis) : 2. Daha (burning) : 3. Strava (oozing) : 4. Rukshata (Dryness) : 5. Pidikotpatti (Eruption) : 6. Vaivarnyata (Discolouration) : 7. Rajii (Thickening of skin) : • Quantitative Variables :
Lab Investigation : The following investigation will be done on 0th day and end of the trial. Following laboratory investigations will be performed for proper diagnosis and to rule out major pathological conditions: • Hematological parameters : CBC (Hemoglobin%, TLC, DLC), ESR • Biochemical parameters : Random Blood Sugar (RBS) • Renal Function Test : Blood urea, Sr. Creatinine • Liver Function Test : SGOT, SGPT
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