| CTRI Number |
CTRI/2018/12/016752 [Registered on: 20/12/2018] Trial Registered Prospectively |
| Last Modified On: |
11/12/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison of Haritaki Draksha avaleha and Aargwadh phalmajja avaleha in the Treatment of Constipation in the age group of 5 to 10 years |
|
Scientific Title of Study
|
"A Comparitive Clinical Study on role of Haritaki Draksha Avaleha and Aargwadh phalmajja Avaleha in the management OF Malvibandh with speacial reference to Functional Constipation in
Children(5-10 YEARS)" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kalyani Hembade |
| Designation |
PG Student |
| Affiliation |
PDEAS College Of Ayurveda And Research Centre |
| Address |
PDEAS College Of Ayurveda And Research Centre 3rd floor Kaumarbhritya department
sector no 25 nigdi pradhikaran pune 411044
PDEAS Ayurveda Rugnalaya and Streling Multispeaciality Hospital opd no 118 Balrog Deaprtnment Sector 27Nigadi Pradhikaran pune 411044
Pune
MAHARASHTRA
411044
India |
| Phone |
8237370911 |
| Fax |
|
| Email |
kalyani2103@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepa Satish Khasgiwala |
| Designation |
BAMS MS |
| Affiliation |
PDEAS College Of Ayurveda And Research Centre |
| Address |
PDEAS College Of Ayurveda And Research Centre 3rd floor Kaumarbhritya department
sector no 25 nigdi pradhikaran pune
PDEAS Ayurved Rugnalaya & Sterling Multispeciality Hospital OPD No. 118 Balrog department sector 27 nigdi pradhikaran
Pune
MAHARASHTRA
41044
India |
| Phone |
9890077765 |
| Fax |
|
| Email |
drvkshinde@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepa Satish Khasgiwala |
| Designation |
BAMS MD |
| Affiliation |
PDEAS College Of Ayurveda And Research Centre |
| Address |
PDEAS College Of Ayurveda And Research Centre 3rd floor Kaumarbhritya department
sector no 25 nigdi pradhikaran pune
PDEAS Ayurved Rugnalaya & Sterling Multispeciality Hospital OPD no. 118 Balrog Department sector 27 nigdi pradhikaran
Pune
MAHARASHTRA
41044
India |
| Phone |
9890077765 |
| Fax |
|
| Email |
drvkshinde@yahoo.com |
|
|
Source of Monetary or Material Support
|
| PDEAS College Of Ayurveda And Research Centre 3rd floor Kaumarbhritya department Akurdi Pune Nigadi Pradhikarn Sctor no 25 Pune 44 |
|
|
Primary Sponsor
|
| Name |
Principal PDEAS College Of Ayurveda And Research Centre |
| Address |
PDEAS College Of Ayurveda And Research Centre sector 22 nigdi pradhikaran 411044 |
| 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 Kalyani D Hembade |
Ayurveda Rugnalay and Sterling Multispeaciality Hospital Nigadi |
Ayurveda Rugnalay and Sterling Multispeaciality Hospital OPD no. 118 Bhel Chowk Nigadi
Pune
MAHARASHTRA |
8237370911
kalyani2103@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: K638||Other specified diseases of intestine, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Haritaki-Draksha avaleha |
Haritaki-Draksha Avaleha is Prepared by Avaleha Kalpana and will be given orally to the children in between 5-10 years of age. the dose is calculated by clarks rule which is 0.6gm/kg/dose and will be given twice a day for 15 days which includes Follow up on 3rd, 5th , 7th and 15th day |
| Comparator Agent |
Aaragwadha phalmajja avaleha |
Aaragwadha phalmajja Avaleha is Prepared by Avaleha Kalpana and will be given orally to the children in between 5-10 years of age. the dose is calculated by clarks rule which is 0.6gm/kg/dose and will be given twice a day for 15 days which includes Follow up on 3rd, 5th , 7th and 15th day |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1)Subjects having age group of 5 to 10 years will be selected irrespective of Gender, caste & religion with following criteria.
2) Children fulfilling ROME ||| CRITERIA
(Must include 2 or more of the following in a child with developmental age of minimum 4 years)
∙Two or fewer defecations in the toilet per week
∙At least one episode of fecal incontinence per week
∙History of painful or hard bowel movements
∙Presence of a large fecal mass in the rectum
∙History of large diameter stools which may obstruct the toilet. 3) Abdominal pain
4) Anorexia
5) Parent’s consent below 7 years and child assent form after 7 years. |
|
| ExclusionCriteria |
| Details |
∙Presence of other organic disorders as Hirschsprungs disease
∙Other systemic illness like T.B, H.I.V etc.
∙Hormonal diseases as Hypothyroidism etc.
∙Irritable Bowel Syndrome |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the role of Haritaki-draksha avaleha and aaragwadha phalmajja avaleha in the management of malvibandha. |
15 days with follow up on 5th, 10th and 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To study the effect of Haritaki-Draksha avaleha
2)To study the effect of Aaragwadha phalmajja avaleha
3)To observe the adverse effect of haritaki-Draksha avaleha and Aaragwadha phal majja avaleha ,if any. |
15 days |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
31/12/2018 |
| 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
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The aim of Management of Functional Constipation is to Promote regular Bowel Movements.Malvibandh needs Anulomak chikitsa .Haritaki Draksha and Aargwadh Phalmajja play important role in the managemnt of Constipation Haritaki have Properties like Deepan, Anuloman, Vibhandhghana as mentioned in Bhavprakash nighantu Along with that Draksha has Properties like srushtamutravita which means it helps in regulating Bowel Movements. Aarghwadh Phalmajja is sransanuttama as mentioned in Bhavprakash nighantu. hence, The Comparison between both the drugs has been taken for research work. |