| CTRI Number |
CTRI/2024/05/067878 [Registered on: 24/05/2024] Trial Registered Prospectively |
| Last Modified On: |
03/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Evaluate the Comparative Efficacy of Bimbimoola Avaleha along with Syp. Shankhapushpi and Shiropichu along with Matrabasti with Bala Taila in Shayyamutra in children. |
|
Scientific Title of Study
|
A Randomized Clinical study to Evaluate the Comparative Efficacy of Bimbimoola Avaleha along with Syp. Shankhapushpi and Shiropichu along with Matrabasti with Bala Taila in Shayyamutra w.s.r. to Enuresis in Children |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Minakshi |
| Designation |
Professor ,Department Of Kaumarbhritya |
| Affiliation |
RGGPG Ayurvedic College and Hospital,Paprola,kangra |
| Address |
Room no. 218,Anatomy block,RGGPG Ayurvedic College and Hospital,Paprola,Kangra,Himachal Pradesh
176115
INDIA
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418017565 |
| Fax |
|
| Email |
drminakshi2050@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Minakshi |
| Designation |
Professor ,Department Of Kaumarbhritya |
| Affiliation |
RGGPG Ayurvedic College and Hospital,Paprola,kangra |
| Address |
Room no. 218,Anatomy block,RGGPG Ayurvedic College and Hospital,Paprola,Kangra,Himachal Pradesh
176115
INDIA
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418017565 |
| Fax |
|
| Email |
drminakshi2050@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sakshi Dadhwal |
| Designation |
PG Scholar, Department Of Kaumarbhritya |
| Affiliation |
RGGPG Ayurvedic College and Hospital,Paprola,kangra |
| Address |
RGGPG Ayurvedic College and Hospital,Paprola,Kangra,Himachal Pradesh.
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8278820227 |
| Fax |
|
| Email |
sakshidadhwal333@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Govt. Ayurvedic Pharmacy Paprola, Distt. Kangra, Herbal garden and Herbarium, Research Institute in ISM, Joginernagar, Distt. Mandi.(Pincode 175015) India. |
|
|
Primary Sponsor
|
| Name |
RGGPG Ayurvedic College |
| Address |
RGGPG Ayurvedic College and Hospital, Paprola, Kangra 176115 |
| 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 |
| Prof Minakshi |
RGGPG Ayurvedic College, Paprola |
Room no-218, Anatomy
Block, RGGPG
Ayurvedic College and
Hospital, Paprola,
Kangra, Himachal
Pradesh.
Kangra
HIMACHAL PRADESH |
9418017565
drminakshi2050@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Human) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F90-F98||Behavioral and emotional disorders with onset usually occurring in childhood and adolescence. Ayurveda Condition: SAYYA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | Matrabasti and Shiropichu with Bala Taila | (Procedure Reference: 1. Matrabasti (Ka. Khil. Sthan 8/104-109) 2. Shiropichu(Ch.Su.5/81-83), Procedure details: 1.Route of administration - Anorectal
Dosage-The dose of Bala Taila Matra Basti will be decided according to Acharya Kashyap (Khil. Sthan 8/104-109). Administration schedule will be of 21 days (3 sittings of 7 days with 3 days interval).
2.Shiropichu (Ch.Su.5/81-83) Route of adminsteration - Scalp, Duration - 30min -60min.)
| | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Bimbimoola Avaleha, Reference: Bhaisajya Ratnavali ( kshudrarogachiktsa 60/167), Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 90(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: Dose of Bimbimoola avaleha - 90mg/kg/day(2) Medicine Name: Shankhapushpi Syrup, Reference: Charak. Chi. (1-3/30-31), Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 0.7(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: Dose of Shankhapushpi Syrup - 0.7ml/kg/day |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient between 5-16 years of age, irrespective of gender, religion and socio-economic status etc.
2.Patient with complaint of repeated involuntary voiding of urine into bed or clothes.
3.The behaviour is clinically significant as manifested by either a frequency of once a week or more.
4.Parents of the patient willing to participate in the trial
|
|
| ExclusionCriteria |
| Details |
1.Children below 5 years or above 16 years of age.
2.Children with any congenital disorder, syndrome etc.
3.Children with Chronic ailments like Tuberculosis, Malignancy, Cardiac and Renal problems.
4.Children suffering from UTI, Diabetes Mellitus etc.
5.Children suffering from worm infestation.
6.Children with physical disability.
7.Parents of the patient not willing to participate in the trial.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fulfillment of Objective and Subjective criteria |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Control of Enuresis in children |
6 weeks |
|
|
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 2 |
|
Date of First Enrollment (India)
|
15/07/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
I would like to publish my research trial after completion as soon as possible. A total
40 subjects will be studied in two groups. 20 Patients will be managed with Bimbimoola Avaleha along with Syrup Shankhapushpi and 20 Patients will be managed with Shiropichu alonwith Matrabasti with Bala Taila . The outcome
will be analysed based on subjective and objective parameters with appropriate
statistical tools |