| CTRI Number |
CTRI/2019/06/019877 [Registered on: 26/06/2019] Trial Registered Prospectively |
| Last Modified On: |
25/06/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Vidangadi churna in krimi roga. |
|
Scientific Title of Study
|
A Comparative clinical study to evaluate the efficacy of Vidangadi Churna with that of Krimighna Dashemani Churna on Krimi Roga (Worm infestation) in Children. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Masooda |
| Designation |
PG Scholar |
| Affiliation |
All India Institute of Ayurveda |
| Address |
OPD 208, Hospital block, All India Institute of Ayurveda, Gautampuri, Sarita Vihar
All India Institute of Ayurveda, Gautampuri, Sarita Vihar
South West
DELHI
110076
India |
| Phone |
9968522196 |
| Fax |
|
| Email |
ramshanoor12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajagopala Shrikrishna |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Room no. 403, 4th floor Academic block, All India Institute of Ayurveda, Gautampuri, Sarita Vihar
All India Institute of Ayurveda, Gautampuri, Sarita Vihar
South West
DELHI
110076
India |
| Phone |
7600902564 |
| Fax |
|
| Email |
srajagopala@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajagopala Shrikrishna |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Room no. 403, 4th floor Academic block, All India Institute of Ayurveda, Gautampuri, Sarita Vihar
All India Institute of Ayurveda, Gautampuri, Sarita Vihar
South West
DELHI
110076
India |
| Phone |
7600902564 |
| Fax |
|
| Email |
srajagopala@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
All India Institute of Ayurveda, Gautampuri, Sarita Vihar, Delhi-110076 |
| 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 Rajagopala Shrikrishna |
All India Institute of Ayurveda |
Room no. 403, 4th floor, Academic block, All India Institute of Ayurveda, Gautampuri, Sarita Vihar
South West
DELHI |
7600902564
srajagopala@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B820||Intestinal helminthiasis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Krimighna Dashemani Churna |
Krimighna Dashemani Churna 3-6 gms (as per age) in two divided doses per day with honey for a period of 28 days. |
| Intervention |
Vidangadi Churna |
Vidangadi Churna 3-6 gms (as per age) in two divided doses per day with honey for a period of 28 days. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1) Age group- 3 years to 12 years.
2) Children with symptoms of Krimi (worm infestation) and positive stool examination
result for ova and cysts.
3) Children of either gender, irrespective of caste, religion, and socio-economic status
will be taken.
4) Parents/Guardians willing to give informed written consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
1) Children below 3 years and above 12 years of age.
2) Negative Ova or Cysts in stool.
3) Other non-intestinal parasitic infestation.
4) Children with chronic ailments like tuberculosis, malignancy or other severe
conditions etc.
5) Parents/Guardians not willing to give informed written consent to participate in the
study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the clinical features of Krimi Roga. |
0 day, 8th day, 15th day, 22nd day and 29th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Stool examination result negative for ova and cyst.
2) Changes in the haematological and bio-chemical parameters.
3) Changes in the quality of life of the children. |
0 day, 29th day and one during follow up. |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
04/07/2019 |
| 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="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)?
|
|
Brief Summary
|
INTRODUCTION: Helminthic infestations contribute to global burden
of diseases in children, especially
in tropical and subtropical regions. Epidemiological
surveys regarding worm infestation in various part of the country reveal a high
incidence of helminthiasis. Slums and rural areas are highly effected probably
due to defective measures of sewage disposal an poor practices of hygiene. Krimi(Helminthic infestations) can cause health problems in children like nutrients
deficiency, anaemia, skin diseases, diarrhoea, pain in abdomen etc. OBJECTIVES OF THE RESEARCH 1. To assess the Krimighna
effect of Vidangadi churnaby the
reduction/absence of Ova and Cysts or either of them in stool examination. 2. To
assess the effect of Vidangadi churnain
other associated symptoms of krimii.e. 3. To improve the quality of life of the
children.
METHODOLOGY:
TYPE OF STUDY DESIGN: a randomized, SINGLE blind, DOUBLE ARM, INTERVENTIONAL,
comparative STUDY.
SAMPLE SIZE :
60 patients (30 in each group) GROUPING AND DRUG DELIVERY REGIMEN: Group A : Vidangadi Churna twice a day with honey. Group B: Krimighna Dashemani Churna twice a day with honey.
|
S.No
|
Age (Yrs)
|
Dose
(Krimghna dashemani churna /
Vidangadi churna)
|
|
1.
|
3-5
|
3 gm
in divided doses
|
|
2.
|
6-9
|
~=
4.5 gm in divided doses
|
|
3.
|
10-12
|
~=
6 gm in divided doses
|
DURATION: 4 weeks. FOLLOW UP: 1 month with fortnightly visit.
|