| CTRI Number |
CTRI/2025/03/082894 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
10/09/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Camel Milk Powder] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The Effect Of Camel Milk Powder consumption on serum insulin level of Type 2 Diabetic Patients |
|
Scientific Title of Study
|
A Study To assess The Effect Of Camel Milk Powder as an adjuvant therapy on serum insulin level of Type 2 Diabetic Patients Visiting A Tertiary Care Hospital Located In Rural Vadodara, Gujarat |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vedika Walia |
| Designation |
Research Scholar |
| Affiliation |
Sumandeep Vidyapeeth deemed to be university |
| Address |
08 Maitreyi girls hostel Sumandeep Vidyapeeth University At Po Piparia Ta Waghodia Dist Vadodara Gujarat India
Vadodara
GUJARAT
391760
India |
| Phone |
9915782565 |
| Fax |
|
| Email |
mishtiwalia10@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr. Meghana Patel |
| Designation |
Assisstant professor |
| Affiliation |
Sumandeep Vidyapeeth deemed to be university |
| Address |
Sumandeep Vidyapeeth University At Po Piparia Ta Waghodia Dist Vadodara Gujarat India
Vadodara
GUJARAT
391760
India |
| Phone |
9913806877 |
| Fax |
|
| Email |
meghanapatel2412@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vedika Walia |
| Designation |
Research Scholar |
| Affiliation |
Sumandeep Vidyapeeth deemed to be university |
| Address |
08 Maitreyi girls hostel Sumandeep Vidyapeeth University At Po Piparia Ta Waghodia Dist Vadodara Gujarat India
Vadodara
GUJARAT
391760
India |
| Phone |
9915782565 |
| Fax |
|
| Email |
mishtiwalia10@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dhiraj Hospital Piparia, Ta Waghodia, Dist Vadodara - 391760 Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Vedika Walia |
| Address |
08 maitreyi girls hostel Sumandeep vidyapeeth university At Po Piparia Ta waghodia Dist vadodara - 391760 gujarat, India |
| Type of Sponsor |
Other [SELF] |
|
|
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 Vedika |
Dhiraj Hospital |
Room no 209 , Department of Clinical Nutrition and Dietetics, Dhiraj Hospital waghodia, Vadodara
Vadodara
GUJARAT |
09915782565
mishtiwalia10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethics Committee |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Camel Milk Powder |
Duration - 45 days
recruited from - Healthera Nutrascience Pvt Ltd Sidhpur Gujarat |
| Comparator Agent |
Cows Milk |
duration - 45 days
200 ml cows milk will be suggested |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Age more than or equal to 35 years of age, HbA1c more than or equal to 6.5 with T2DM
2.oral hypoglycemic agents – biguanide (metformin), alpha glucosidase inhibitor (AGI), dipeptidyl peptidase-4 (DPP4) inhibitors and diuretics.
3.Willingness to abstain from intake of other milk and milk products during the study.
4.Agree to take camel milk as part of study during the study period.
5.Willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1.Diabetic subjects taking insulin and with diabetic complications such as nephropathy, neuropathy or cardiovascular disease.
2.oral hypoglycemic agents – sulphonylureas, SGLT2 and steroids.
3.pregnant or lactating women.
4.Person having Intolerance to camel milk.
5.Not willing to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| serum insulin and FBS will be estimated |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| body composition |
45 days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
03/05/2025 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
A review article titled
Therapeutic Potential of Camel Milk in Type 2 Diabetes Mellitus :A Review
has been published in Asian Journal of Pharmaceutics, Apr-Jun 2025, 19 (2) edition
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomised controlled trial wherein 80 type 2 diabetes mellitus subjects will be enrolled for the study. 20 grams camel milk powder will be given daily for the period of 45 days. The study will be conducted in tertiary care hospital in Vadodara, Gujarat, India. The primary outcome measures will be FBS and serum insulin levels after 45 days. |