| CTRI Number |
CTRI/2019/06/019569 [Registered on: 07/06/2019] Trial Registered Prospectively |
| Last Modified On: |
04/06/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [vaman ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Eczema- tak vikar with blckish lesion with discharge itching |
|
Scientific Title of Study
|
A Comparative Study on the effect of vaman karma with and without nimb swaras in vicharchika w.s.r Eczema |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ruchi gupta |
| Designation |
Associate professor |
| Affiliation |
Patanjali bhartiya ayurvigyan avam anusandhan sansthan |
| Address |
Opd 4 patanjali yogpeeth phase 1 roorkee delhi highway hardwar uttaranchal
Patanjali bhartiya ayurvigyan avam anusandhan sansthan patanjali ayurveda college hardwar uttaranchal
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9469063888 |
| Fax |
|
| Email |
ruchigupta1610@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ruchi gupta |
| Designation |
Associate professor |
| Affiliation |
Patanjali bhartiya ayurvigyan avam anusandhan sansthan |
| Address |
Opd 4 patanjali yogpeeth phase 1 roorkee delhi highway hardwar uttaranchal
Patanjali bhartiya ayurvigyan avam anusandhan sansthan patanjali ayurveda college hardwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9469063888 |
| Fax |
|
| Email |
ruchigupta1610@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ruchi gupta |
| Designation |
Associate professor |
| Affiliation |
Patanjali bhartiya ayurvigyan avam anusandhan sansthan |
| Address |
Opd 4 patanjali yogpeeth phase 1 roorkee delhi highway hardwar uttaranchal
Patanjali bhartiya ayurvigyan avam anusandhan sansthan patanjali ayurveda college hardwar uttaranchal
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9469063888 |
| Fax |
|
| Email |
ruchigupta1610@gmail.com |
|
|
Source of Monetary or Material Support
|
| Divya pharmacy and SKM siddha and ayurveda |
|
|
Primary Sponsor
|
| Name |
Patanjali ayurved college |
| Address |
Patanjali bhartiya ayurvigyan avam anusandhan sansthan patanjali ayurved hospital |
| 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 |
| Akansha verma |
Patanjali Ayurved College |
Patanjali ayurvedic hospital opd 4 panchkarma department hardwar
Hardwar
UTTARANCHAL |
9410576550
vermaakansha423@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PAC/IEC/2017-18/03 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L309||Dermatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Subjective parameters
1 kandu
2 Rukshata
3 Pidaka
4 Vaivarnata
5 Raha
6 Patches |
comparasion will be done on the basis of subjective parameters pre and post intervention in vaman with and without nimb swaras. |
| Intervention |
vaman with/without nimb swaras |
Deepan paachan- orally Panchkol churna 3gm tds and chitrakadi vati 2tab bd
Snehpaan- orally Tiktak ghrita according to koshta dose will be decided
vaman with/without nimb swaras.total duration 10 days |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.patients fulfilling the classical lakshanas of Vicharchika
2.The patients of either sex between the age group of 16-50 years
3.Patients having chronicity more than 3 months and less than 10 years.
4.Patients fit for Vaman karma will be taken for the study. |
|
| ExclusionCriteria |
| Details |
1.Patients with major systemic diseases(HTN,Diabetes,CAD etc)that may interfere the course of treatment.
2.Patients under corticosteroids and other immune supressants.
3.Pregnent & lactating mothers.
4.Patients with susceptibilty to allergens. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Subjective parameters
kandu
rukshta/srava
pidaka
vaivarnata
daha
patches
Objective parameters
number of vaman vega
timetaken to start vaman
duration of vaman
condition during vega
langiki shudhi laghuta/hridshudhi/parshva shudhi/murdha shudhi/indriyashudhi
antiki shudhi kaphanta/pittanta/no ascess
maniki shudhi svegas/6 vegas/4vegas
type of shudhi pravar/madhyam/avar
chemical analysis of vomitus
|
Just before intervention of vaman with or without Nimb swaras in the management of vicharchika |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Subjective parameters
kandu
rukshta/srava
pidaka
vaivarnata
daha
patches
Objective parameters
number of vaman vega
timetaken to start vaman
duration of vaman
condition during vega
langiki shudhi laghuta/hridshudhi/parshva shudhi/murdha shudhi/indriyashudhi
antiki shudhi kaphanta/pittanta/no ascess
maniki shudhi svegas/6 vegas/4vegas
type of shudhi pravar/madhyam/avar
chemical analysis of vomitus
|
after intervention of vaman with or without Nimb swaras in the management of vicharchika in the first follow up of 1month |
|
|
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 |
|
Date of First Enrollment (India)
|
20/06/2019 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
patient with classical lakshanas of vicharchika will be taken under the intervention. in intervention first deepan paachan will be done with chitrakadi vati and panchkol churna then snehpaan with tiktak ghrita according to koshta and samyak snehan lakshan achieved .then vaman will be done with /without nimb swaras after the intervention, placebo will be given. investigation (cbc with esr.rbs.serum triglycerides,serum cholestrol,sgot,sgpt)will be seen pre and post intervention with follow up of 1 month in 2 group wtth 15 patients in each group. |