| CTRI Number |
CTRI/2021/08/035508 [Registered on: 06/08/2021] Trial Registered Prospectively |
| Last Modified On: |
27/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study of three ayurvedic formulations in fungal infection. |
|
Scientific Title of Study
|
"CLINICAL EVALUATION OF THE EFFICACY OF ‘PANCHTIKTA GHRITA GUGGUL’, ‘KHADIRARISHTA’ AND ‘EDGAJADI LEPA’ IN DADRU [TAENIA CORPORIS]" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Shivani Rawat |
| Designation |
MD SCHOLAR |
| Affiliation |
PATANJALI BHARTIYA AYURVIGYAN AVAM ANUSANDHAN SANSTHAN, HARIDWAR |
| Address |
OPD NO. 12 ,DEPARTMENT OF KAYACHIKITSA, PATANJALI AYURVEDIC HOSPITAL, HARIDWAR
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8859865042 |
| Fax |
|
| Email |
Shivanirawatofficial@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ABHISHEK BHUSHAN SHARMA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
PATANJALI BHARTIYA AYURVIGYAN AVAM ANUSANDHAN SANSTHAN, HARIDWAR |
| Address |
OPD NO. 12, DEPARTMENT OF KAYACHIKITSA ,PATANJALI AYURVEDIC HOSPITAL, HARIDWAR
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9458636020 |
| Fax |
|
| Email |
ayu.abhishek@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ABHISHEK BHUSHAN SHARMA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
PATANJALI BHARTIYA AYURVIGYAN AVAM ANUSANDHAN SANSTHAN, HARIDWAR |
| Address |
OPD NO. 12, DEPARTMENT OF KAYACHIKITSA ,PATANJALI AYURVEDIC HOSPITAL, HARIDWAR
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9458636020 |
| Fax |
|
| Email |
ayu.abhishek@gmail.com |
|
|
Source of Monetary or Material Support
|
| PATANJALI AYURVEDIC HOSPITAL, PATANJALI AYURVIGYAN AVAM ANUSANDHAN SANSTHAN, HARIDWAR |
|
|
Primary Sponsor
|
| Name |
Patanjali Ayurveda College |
| Address |
Patanjali Bhartiya Ayurvigyan Avam Anusandhan Sansthan |
| Type of Sponsor |
Research institution and hospital |
|
|
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 SHIVANI RAWAT |
PATANJALI AYURVED HOSPITAL |
OPD NO. 12, DEPARTMENT OF KAYACHIKITSA, PATANJALI BHARTIYA AYURVIGYAN AVAM ANUSANDHAN SANSTHAN, HARIDWAR, 249405
Hardwar
UTTARANCHAL |
8859865042
Shivanirawatofficial@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PAC/IEC/2019-20/14 |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L089||Local infection of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: DADRU-KUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | lepaH (viShopakramaH), लेपः (विषोपकà¥à¤°à¤®à¤ƒ) | (Procedure Reference: Chakradatta 50:36 , Procedure details: Local Application as per requirement)
| | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Panchatikta Ghrita Guggulu, Reference: Chakradatta 50:118-121, Route: Oral, Dosage Form: Guggulu , Dose: 2(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: Llukewarm Water), Additional Information: | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Khadirarishta, Reference: Sharangdhar Samhita Madhyam Khand 10:60-63 1/2, Route: Oral, Dosage Form: Arishta, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: Water), Additional Information: |
|
|
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Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
a) Patient with signs and symptoms of Dadru and taenia corporis were included in the study.
b) Age group above 16 to 60 years randomly included for study.
c) Patients of both sex included for the study.
d) Patients having history of less than two years of onset of disease.
e) Both fresh and treated cases would be taken for the study.
|
|
| ExclusionCriteria |
| Details |
a) Patients under long standing medication.
b) Pregnant women and lactating women.
c) Chronicity more than 2 years.
d) Age group below 16 years and above 60 years.
e) Patient suffering from uncontrolled DM.
f) Patient undergone recent surgeries.
|
|
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Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Subject Parameter - Grading will be done considering signs and symptoms of dadru- Kandu, Raga,Pidika, Utsannamandal
Objective Parameter-
Size of Mandal is assessed |
Before intervention of the drugs for one month with Panchatikta Ghrita Guggulu and Khadirarishta orally,Edgajadi Lepa locally. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Subject Parameter - Grading will be done considering signs and symptoms of dadru- Kandu, Raga,Pidika, Utsannamandal
Objective Parameter-
Size of Mandal is assessed |
After intervention of one month with Panchatikta Ghrita Guggulu and Khadirarishta orally,Edgajadi Lepa locally. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 |
|
Date of First Enrollment (India)
|
10/08/2021 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
NOT YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this trial, we are selecting patient of Dadru (Taenia corporis) in which we will do intervention in single group. We will intervene oral and local administration of ayurvedic drugs (Panchatikta Ghrita Guggulu, Khadirarishta, Edgajadi Lepa). Assessment will be done on basis of subjective & objective parameters. Dose of medicine- Panchatikta Ghrita Guggulu 2 tablets twice daily with luke warm water. Khadirarishta 20 ml with equal amount of water twice daily. Edgajadi Lepa local application. Route of administration- Panchatikta ghrita guggulu and Khadirarista orally, Edgajadi lepa local application. Follow-up- The follow up will be done after 15 days and 1 month during the trial of 1 month to observe the effects of treatment or any adverse effects on patient.
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