| CTRI Number |
CTRI/2022/11/047116 [Registered on: 07/11/2022] Trial Registered Prospectively |
| Last Modified On: |
09/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical Trial to evaluate the effects of Dibosudha tablet and Diabosudha Liquid Diabetes Mellitus type 2. |
|
Scientific Title of Study
|
An Open Label, Single arm, prospective, Clinical study to evaluate efficacy and safety of Diabosudha Tablet and Diabosudha Liquid in Subjects with Mild to Moderate Diabetes Mellites Type 2. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SAPL-DIB-22-05 Version 1.0 Dated 18-Jun-2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Harshala Rajurkar Sharma |
| Designation |
Principal Investigator |
| Affiliation |
Datta Meghe Ayurvedic medical College Hospital and Research Center |
| Address |
Department of Medicine
Datta Meghe Ayurvedic medical College Hospital and Research Center
Wanadongri, Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
|
| Fax |
|
| Email |
harshalasharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhijit Munshi |
| Designation |
Director Clinical Operations |
| Affiliation |
Alchemy Clinical Research Services |
| Address |
38 LIG So, Somalwada Road
Manish Nagar
Nagpur
MAHARASHTRA
440015
India |
| Phone |
9822371703 |
| Fax |
|
| Email |
drabhijit@alchemyclinical.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shailesh Malekar |
| Designation |
Consultant |
| Affiliation |
Sahyadri Ayurvedic Life Pvt. Ltd. |
| Address |
Research Department. Ground Floor, room no 4, 310, 1/C Sahyadri Ayurvedic Life
Patkhal, satara, Maharashtara
Satara
MAHARASHTRA
415011
India |
| Phone |
|
| Fax |
|
| Email |
vdshailesh@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Sahyadri Ayurvedic Life Pvt. Ltd. |
|
|
Primary Sponsor
|
| Name |
Sahyadri Ayurvedic Life Pvt. Ltd. |
| Address |
310, 1/C Sahyadri Ayurvedic Life patkhal, satara, Maharashtara -415011 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Harshala Rajurkar Sharma |
Datta Meghe Ayurvedic medical College Hospital and Research Center |
Department of Medicine
Datta Meghe Ayurvedic medical College Hospital and Research Center
Wanadongri, Nagpur
Nagpur
MAHARASHTRA |
9067317029
harshalasharma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Shalinitai Meghe Hospital and Research Center |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Diabosudha Tablet, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Diabosudha Liquid, Reference: NA, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Gender: Either male or non-pregnant, non-lactating female aged > 18-70 < years (both inclusive).
2. Type 2 diabetes subjects (diagnosed clinically) ≥ 6 months prior to screening.
3. HbA1c ≥ 7.0 % and ≤ 10.0 % (both inclusive).
4. Subjects willing to give written informed consent.
5. Subjects able to comply with the study protocol.
6. Women of child bearing potential must have a negative urine pregnancy test prior to study entry.
7. Are willing to avoid participation in any other interventional clinical trial for the duration of this study. |
|
| ExclusionCriteria |
| Details |
1. Suspected or confirmed pregnancy.
2. Diagnosis of any known chronic or acute medical disease of any kind (e.g., cardiovascular disease, respiratory disease, influenza, pneumonia, etc.)
3. Diagnosis of any known neurological disease or psychological disorder of any kind (e.g., brain lesion, epilepsy, anxiety, eating disorder, mood disorder, sleep disorder, etc.)
4. Any implanted electrical medical device (e.g., pacemaker, insulin pump, deep brain stimulator, etc.)
5. Any form of prescription medication.
6. Use of antibiotics in the three months prior to enrolment.
7. A direct or familiar relationship with the Sponsor, Investigator, or site personnel affiliated with the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| •Change in level of HbA1c from baseline |
Day 0 To Day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • Change in lipid panel test values |
Day 0 To Day 90 |
| • Change in patient reported outcome for weight increase/ decrease, hunger and thirst and frequent urination at various follow up appointments |
Day 0 To Day 90 |
| • Change in BSL values |
Day 0 To Day 90 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
10/11/2022 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Suspended |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is designed as an Open Label,
Single arm, prospective, Clinical study to evaluate efficacy and safety of
Diabosudha Tablet and Diabosudha Liquid in Subjects with Mild to Moderate
Diabetes Mellites Type 2.
All the subjects will receive DIBOSUDHA
Tablet and Liquid as a test product. Subjects fulfilling the inclusion and
exclusion criteria will be enrolled in the study. Enrolled subjects will be
under treatment for 12 weeks.
The study will include 2 periods for a total
of up to 13 weeks:
1. Screening Period: There will be a period up
to 1 week for subject screening, based on medical history, physical examination
and clinical laboratory investigations and meeting all inclusion and exclusion
criteria.
After signing the informed consent, subjects will undergo screening
procedures and Assessment.
2. Baseline: Safety parameters like hematology and biochemistry
will be assessed at baseline and at week 12.
3. Treatment period (12 weeks):
The
treatment period will consist of 12 weeks of treatment with study medication,
starting on Day 0. Treatment visits will occur at Weeks 4, 8 and 12 of the
treatment period. HbA1c will be measured at End-of- Treatment/Early Termination
visit (Week 12) and BSL will be measured at every visit.
Subjects who meet protocol discontinuation criteria will be asked to
return to the clinic for follow-up assessment and confirmation of values prior
to discontinuation.
Discontinued subjects must complete Early Termination Visit procedures.
The study is designed as an Open Label,
Single arm, prospective, Clinical study to evaluate efficacy and safety of
Diabosudha Tablet and Diabosudha Liquid in Subjects with Mild to Moderate
Diabetes Mellites Type 2.
All the subjects will receive DIBOSUDHA
Tablet and Liquid as a test product. Subjects fulfilling the inclusion and
exclusion criteria will be enrolled in the study. Enrolled subjects will be
under treatment for 12 weeks.
The study will include 2 periods for a total
of up to 13 weeks:
1. Screening Period: There will be a period up
to 1 week for subject screening, based on medical history, physical examination
and clinical laboratory investigations and meeting all inclusion and exclusion
criteria.
After signing the informed consent, subjects will undergo screening
procedures and Assessment.
2. Baseline: Safety parameters like hematology and biochemistry
will be assessed at baseline and at week 12.
3. Treatment period (12 weeks):
The
treatment period will consist of 12 weeks of treatment with study medication,
starting on Day 0. Treatment visits will occur at Weeks 4, 8 and 12 of the
treatment period. HbA1c will be measured at End-of- Treatment/Early Termination
visit (Week 12) and BSL will be measured at every visit.
Subjects who meet protocol discontinuation criteria will be asked to
return to the clinic for follow-up assessment and confirmation of values prior
to discontinuation.
Discontinued subjects must complete Early Termination Visit procedures.
AE/SAE
will be recorded during the conduct of the study. |