| CTRI Number |
CTRI/2024/04/066012 [Registered on: 19/04/2024] Trial Registered Prospectively |
| Last Modified On: |
05/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Adjuvant Effect Of Nisha-Amlaki And Mahadadimadi Ghrita With Insulin In Diabetes Type I In Pediatric Population |
|
Scientific Title of Study
|
A RANDOMIZED, OPEN LABEL, PLACEBO CONTROLLED STUDY
TO EVALUATE THE ROLE OF TAB NISHA-AMALAKI AND
MAHADADIMADI GHRITA AS ADJUVANT THERAPY IN TYPE 1
DIABETES (SAHAJA PRAMEHA) 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 |
Gourav Kumar Rathor |
| Designation |
Ph. D Scholar |
| Affiliation |
All India Institute of Ayurevda, New Delhi |
| Address |
Dept. of Kaumarbhritya, All India Institute of Ayurveda, New Delhi
South
DELHI
110076
India |
| Phone |
989390810 |
| Fax |
|
| Email |
gouravrathor1991@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajagopala S |
| Designation |
Associate Professor Dept. of Kaumarbhritya |
| Affiliation |
All India Institute of Ayurveda New Delhi |
| Address |
Dept of Kaumarbhritya All India Institute of Ayurvda New Delhi
South
DELHI
110076
India |
| Phone |
9893908190 |
| Fax |
|
| Email |
srajagopala@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajagopala S |
| Designation |
Associate Professor Dept. of Kaumarbhritya |
| Affiliation |
All India Institute of Ayurveda New Delhi |
| Address |
Dept of Kaumarbhritya All India Institute of Ayurvda New Delhi
South
DELHI
110076
India |
| Phone |
9893908190 |
| Fax |
|
| Email |
srajagopala@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda, New Delhi |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda, New Delhi |
| Address |
All India Institute Of Ayurevda, Sarita Vihar, Mathura Road, New Delhi |
| 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 Gourav Kumar Rathor |
All India Institute of Ayurveda, New Delhi |
OPD No. 208/207, 2nd floor, All India Institute of Ayurveda, New Delhi
South
DELHI |
9893908190
gouravrathor1991@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee All Inida Instituteof Ayurveda, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E109||Type 1 diabetes mellitus without complications. Ayurveda Condition: PRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Nisha Amalaki, Reference: Astnag Hridya, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 6 Months, anupAna/sahapAna: Yes(details: - Ushna Jala), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Mahadadimadi Ghirta , Reference: Chakradutta , Route: Oral, Dosage Form: Ghrita, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 6 Months, anupAna/sahapAna: Yes(details: -Ushna Jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 02 -16 years.
2. Pre-diagnosed cases of T1DM (Type 1 diabetes)
3. Patients having FBS ≥126mg/dl, PPBS ≥200 mg/dl, HbA1c ≥ 6.5%
4. Requirement of insulin as the initial mode of treatment at the time of diagnosis of diabetes.
5. Brittle diabetes (mellitus)
6. Diabetes (mellitus) due to autoimmune process
7. Diabetes (mellitus) due to immune mediated pancreatic islet beta-cell destruction
8. Idiopathic diabetes (mellitus)
9. Juvenile onset diabetes (mellitus)
|
|
| ExclusionCriteria |
| Details |
1. Patient age less than two year and more than 16 year
2. Patients of type 2 diabetes.
3. Any systematic and severe illness requiring hospitalization.
4. History of hypersensitivity to any drug.
5. Patients whose parents are not willing to give consent for clinical trial.
6. Active case of DKA and blood glucose level more than 600 mg/dl.
7. Ketosis-prone diabetes (mellitus), gestational diabetes.
8. Hyperglycemia NOS
9. Neonatal diabetes mellitus
10. Post pancreatectomy diabetes mellitus.
11. Post procedural diabetes mellitus.
12. Secondarydiabetes mellitus NEC. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in HBA1C, FBS, PPBS level and Serum Insulin |
FBS, PPBS level and Serum Insulin. Baseline, after every month and Hb1AC assessed Baseline, after 3rd month and
6
th months and for the assessment in the present study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
➢ Reduction in dose of insulin per day.
25
➢ Relief in sign & symptoms of Sahaj Prameha.
➢ Improvement in QOL of children with Type 1 Diabetes Mellitus
|
6 month |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
01/05/2024 |
| 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="6"
Days="15" |
|
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
|
patients of diabetes mellitus type I will be randomly selected into two groups group 1 will be provided with Nisha-amlaki tablet and Mahadadimadi ghrita along with SOC while patients of group 2 will be given SOC patients will be kept under follow for period of 1month |