| CTRI Number |
CTRI/2022/10/046146 [Registered on: 04/10/2022] Trial Registered Prospectively |
| Last Modified On: |
02/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Shunthyadi yoga granules and Pippliyadi tail Matra basti in Vibandh(functional constipation) |
|
Scientific Title of Study
|
A Clinical study to evaluate the Comparative efficacy of Shunthyadi yoga granules and Pippliyadi tail Matra basti in Vibandh w.s.r to functional Constipation 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 Minakshi |
| Designation |
Reader,Department of Kaumarbhritya |
| Affiliation |
RGGPG Ayurvedic College and Hospital |
| Address |
Room no. 218 Dept of kaumarbhritya RGGPG Ayu. College, Paprola,Teh.-Baijnath, Distt.-Kangra, H.P. ,PIN-176115
RGGPG Ayu. College, Paprola,Teh.-Baijnath, Distt.-Kangra, H.P. ,PIN-176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418017565 |
| Fax |
|
| Email |
drminakshi2050@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Minakshi |
| Designation |
Reader,Department of Kaumarbhritya |
| Affiliation |
RGGPG Ayurvedic College and Hospital |
| Address |
Room no. 218 Dept of kaumarbhritya RGGPG Ayu. College, Paprola,Teh.-Baijnath, Distt.-Kangra, H.P. ,PIN-176115
RGGPG Ayu. College, Paprola,Teh.-Baijnath, Distt.-Kangra, H.P. ,PIN-176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418017565 |
| Fax |
|
| Email |
drminakshi2050@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deeksha Dhiman |
| Designation |
PG Scholar |
| Affiliation |
RGGPG Ayurvedic College and Hospital |
| Address |
RGGPG Ayu. College, Paprola,Teh.-Baijnath, Distt.-Kangra, H.P. ,PIN-176115
RGGPG Ayu. College, Paprola,Teh.-Baijnath, Distt.-Kangra, H.P. ,PIN-176115
Kangra
HIMACHAL PRADESH
176063
India |
| Phone |
9780774872 |
| Fax |
|
| Email |
ddeeksha01@gmail.com |
|
|
Source of Monetary or Material Support
|
| RGGPG ayurvedic college and hospital paprola district kangra |
|
|
Primary Sponsor
|
| Name |
RGGPG Ayurvedic College and hospital paprola district kangra |
| Address |
Department of kaumarbhritya RGGPG Ayurvedic College and hospital paprola |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Minakshi |
Room no. 218 Dept of kaumarbhritya RGGPG Ayurvedic College and hospital paprola 176115 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Minakshi Chaudhary |
Regional Ayurvedic Hospital Paprola |
Room no. 218, Department of Kaumarbhritya, RGGPG Ayu. College and Hospital Paprola Distt Kangra HP Pin Code -176115
Kangra
HIMACHAL PRADESH |
9418017565
drminakshi2050@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K21||Gastro-esophageal reflux disease. Ayurveda Condition: VIBANDHA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Suthyadi Yoga Granules, Reference: Astang Hridya, Route: Oral, Dosage Form: Khanda /Granules, Dose: 80(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: Milk), Additional Information: - |
|
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Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients coming with complaints of vibandh. 2)Patients between 2-16 years of age irrespective of gender. 3)Patients fulfilling the Rome IV criteria. 4)Parents of patient willing to participate in the trial. |
|
| ExclusionCriteria |
| Details |
1)Children below 2 years of age and above 16 years of age. 2)Patient suffering from constipation due to organic causes. 3)Children with congenital anomaly. 4)Children with chronic ailmets like tuberculosis,malignancy, cardiac and renal problems. 5)Children suffering from UTI, diabetes mellitus etc.6)Children with physical disability. 7)Children below or above the mentioned age group. 8)Parents of patients not willing to participate in the trial. |
|
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Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Children fullfill the ROME IV Criteria of Functional Constipation Must include Two or more of the following. 1)Two or fewer Defecations in the toilet per week.
2)Atleast one episode of faecal incontinence.
3)History of retentive Posturing or excessive volitional stool retention.
4)History of Painful or Hard Bowel movement.
5)Presence of large faecal mass in the rectum.
|
4 weeks time period for Drug (Shunthyadi Granules).
3 weeks time period for Procedure with three sittings of seven days with three days interval (Pippalyadi Matra Basti) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Children fullfill the ROME IV Criteria of Functional Constipation Must include 2 or more of the following
1)Two or fewer Defecations in the toilet per week
2)Atleast one episode of faecal incontinence per week.
3)History of retentive Posturing or excessive volitional stool retention 4)History of Painful or Hard Bowel movement.
5) Presence of large faecal mass in the rectum.
6)Complete remission of signs and symptoms. |
4 weeks Time period for Drug (Shunthyadi Granules)and 3 weeks time period for Procedure with three sittings of seven days with three days interval (Pippalyadi Matra Basti). Follow up after 2 weeks and after completion of trial |
|
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Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/10/2022 |
| 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 Yet Recruiting |
| 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)?
Response - NO
|
|
Brief Summary
|
Effect of shunthyadi yoga granules and pippliyadi tail matra basti on the patients of vibandh w.s.r to functional constipation will be assessed in group A and group B. Group A will be treated with shunthyadi yoga granules and group B will be treated with pippliyadi tail matra basti. Purpose of the trial is to provide relief from symptoms. |