| CTRI Number |
CTRI/2019/04/018610 [Registered on: 15/04/2019] Trial Registered Prospectively |
| Last Modified On: |
12/04/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study of Vidangadi yog and Nimbadi yog in the management of mrudbhakshan(Consumption of mud)(geophagia)in children. |
|
Scientific Title of Study
|
A standard controlled clinical trial of Vidangadi yoga and Nimbadi yoga in the management of mrudbhakshan(geophagia)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 Meenaj A Mulla |
| Designation |
PG Student |
| Affiliation |
PDEAS College of Ayurveda And Research Centre Akurdi pune |
| Address |
PDEAS College of Ayurveda And Research Centre sector 25 nigadi pradhikaran pune Ayurveda Rugnalaya And Sterling Multispeciality hospital sector 27nigdi pradhikaran pune 44 O/P/D No.118
Pune
MAHARASHTRA
411044
India |
| Phone |
9075333044 |
| Fax |
|
| Email |
mullameenaj91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSudha Singh |
| Designation |
M.D(Kaumarbhritya) |
| Affiliation |
PDEAS College of Ayurveda And Research Centre Akurdi pune |
| Address |
PDEAS College of Ayurveda And Research Centre sector No 25 nigadi pradhikaran pune Ayurveda Rugnalaya And Sterling Multispeciality Hospital sector 27 nigdi pradhikaran pune 44 O/P/D No.118
Pune
MAHARASHTRA
411044
India |
| Phone |
9975404439 |
| Fax |
|
| Email |
drsudha2010@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meenaj A Mulla |
| Designation |
PG Student |
| Affiliation |
PDEAS College of Ayurveda And Research Centre Akurdi pune |
| Address |
PDEAS College of Ayurveda And Research Centre sector No 25 nigadi pradhikaran pune. Ayurveda Rugnalaya and Sterling Multispeciality Hospital sector 27 nigdi pradhikaran pune 44 O/P/D No.118
Pune
MAHARASHTRA
411044
India |
| Phone |
9075333044 |
| Fax |
|
| Email |
mullameenaj91@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAS College of ayurved and research centre akurdi pune nigdi pradhikaran sector 25 pune 44 |
|
|
Primary Sponsor
|
| Name |
CARC Nigdi Pune |
| Address |
Nigdi Pradhikaran Sector 25 Akurdi Pune |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrMeenaj ARahiman Mulla |
Ayurveda Rugnalay and Sterling Multispeciality Hospital Nigdi |
Ayurveda Rugnalaya OPD room no 118 Balrog Department Ayurveda division Sector 27 Nigdi Pradhikaran pune
Pune
MAHARASHTRA |
9075333044
-----
mullameenaj91@gmail.com |
| DrMeenaj ARahiman Mulla |
CARC College |
College of Ayurveda And Research Centre 3rd floor Kaumarbhritya department sector no 25 nigdi pradhikaran pune
Pune
MAHARASHTRA |
9075333044
mullameenaj91@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: D50-D89||Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nimbadi yoga |
Nimbadi yoga is prepared by churna kalpana and will be given orally to the children in between 18 month to 5 years of age the dose is calculated by clarks rule which is 7mg/kg/dose and will be given twice a day for 28 days which includes follow up 7th ,14th ,21th ,28th day. |
| Intervention |
Vidangadi yoga |
Vidangadi yoga is prepared by churna kalpana and will be given orally to the children in between 18 month to 5 years of age the dose is calculated by clarks rule which is 7mg/kg/dose and will be given twice a day for 28days which includes follow up 7th ,14th, 21th,28th day. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Month(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
1)Subjects having age group of 18 months to 5yrs will be selected.
2)H/O-Eating mud for more than 1 month
3)According to Ayurved symptoms-Shuna-(swelling)over nabhi,pada,asya,mehan
Loose and hard stools etc |
|
| ExclusionCriteria |
| Details |
1)Acute infection of gastrointestinal tract.
2)Known case of renal disorder(chronic renal failure).
3)Known case of metabolic disorders(hypoglycemia).
4)Known case of congenital anomalies etc.
5)Known case of epilepsy. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of Vidangadi yoga and Nimbadi yoga in the management of mrudbhakshan. |
28 days with follow up at 7th,14th.21th,28th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the adverse effect of Vidangadi yoga with Nimbadi yoga in the management of mrudbhakshan,if any. |
28 days with follow up at 7th,14th.21th,28th day
|
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
06/05/2019 |
| 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
|
There are various Psychosomatic disorders seen in pediatric population.Pica as persistent eating of non-nutrient substances such as soil, chalk, paper, dry wall paint etc. Geophagia is a type of pica, deliberat consumption of earth, soil or clay. commonly occurence among very young children of both genders.The incidence of pica is estimated to be 75% in infant ,15% in 2-3 years old toddlers. In ayurveda , pica can be correlated with mrudbhakshan as explain by charak, vagbhat. Many recipes have been described to get rid of geophagia because practically it is not stopped only by supplementation of iron and calcium. |