| CTRI Number |
CTRI/2023/10/058181 [Registered on: 03/10/2023] Trial Registered Prospectively |
| Last Modified On: |
30/09/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Foxtail Millet Powder With
Low Salts In Stage 3 Chronic Kidney Disease patients |
|
Scientific Title of Study
|
A Controlled Open Label Single Arm Proof Of Concept Study To
Evaluate The Safety Of De-NaPKC Foxtail Millet Powder With
Low Salts In Stage 3 Chronic Kidney Disease In Indian Population. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| De-NaPKC/15/23 Version:1.0 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Venkatram Murugesan |
| Designation |
Consultant Nephrologist, interventionist and transplant physician. Director - East Coast Hospitals |
| Affiliation |
East Coast Hospitals |
| Address |
General Medicine OPD, Room no. 10,East coast Hospital, No 1, Paris Nagar, Moolakulam, Puducherry – 605 010
Pondicherry
PONDICHERRY
Pondicherry
PONDICHERRY
605010
India |
| Phone |
9042846842 |
| Fax |
|
| Email |
drvenkatram@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Sakthi Balan MD |
| Designation |
Consultant |
| Affiliation |
Thirumalai medical Centre, ki3 |
| Address |
Thirumalai Medical Centre, Room No 1. Thirumalai Medical Centre, No 408 Cuddalore Road Nainarmandapam Puducherry
Pondicherry
PONDICHERRY
605004
India |
| Phone |
9443627722 |
| Fax |
|
| Email |
saheerose@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayathri Sivakumar |
| Designation |
CEO |
| Affiliation |
KI3, CRO |
| Address |
Room No1, KI3 office, Regus Centre Level 2 Altius Block, No1 SIDCO Industrial Estate, Chennai
Chennai
TAMIL NADU
600044
India |
| Phone |
9003109416 |
| Fax |
|
| Email |
drgayathri@ki3services.com |
|
|
Source of Monetary or Material Support
|
| BR Medical Research and software solutions OPC Private limited, 1-6-4, sri ram nagar colony, annupuram, sainik puri, Hyderabad, Telangana 500062 |
|
|
Primary Sponsor
|
| Name |
BR Medical Research and software solutions OPC Private limited |
| Address |
1- 6-4, ,, ANUPURAM SANIKPURI, HYDERABAD,
Telangana, 500062 |
| 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 Venkatram Murugesan |
East Coast Hospital |
General Medicine OPD, Room no. 10,East coast Hospital,
No 1, Paris Nagar, Moolakulam, Puducherry – 605 010
Pondicherry
PONDICHERRY |
9042846842
drvenkatram@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHIQUE DE LA NATURE ASSOCIATION |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N183||Chronic kidney disease, stage 3 (moderate), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
De Mineralized Foxtail Millet Ready to Cook |
Foxtail Millet 100gm powder taken in the morning instead of breakfast Total Duration: One Week |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Willing and able to provide written informed consent prior to
performing study procedures.
2. Patients between the age of 45 to 65 years, male or female.
3. Patients in stage III CKD and who are on salt restricted diet and
able to drink 350 ml/day.
4. Females must be non-pregnant / non-lactating and practicing
adequate birth control measures if not menopausal.
5. Patient should have not participated in any other clinical trial
during the past 3 months. |
|
| ExclusionCriteria |
| Details |
1. Patient who are unable to consume solid and liquid orals.
2. Having active infection
3. Very high level of creatinine (>4 mg/dl).
4. Hypersensitivity to test product.
5. History of drug or alcohol abuse.
6. Consideration by the investigator, for any reason, that the
subject is an unsuitable candidate to receive study treatment. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Each patient will be monitored for any adverse drug reaction.
Other Safety parameters includes monitoring for any change
in the blood parameters.
2) Other parameters monitored include; Nausea, Vomiting,
Gastritis, ability to consume 350 ml, skin reaction, able to
pass stool comfortably, any event of hypoglycemic in
diabetic patient, palpitation, hypertensive or hypotensive
episodes and weight gain or loss. |
Day 0, Day 7, Day 15 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To monitor for any changes in any of the Laboratory parameters pre
and post study. |
Day 0, Day 7, Day 15 |
|
|
Target Sample Size
|
Total Sample Size="11"
Sample Size from India="11"
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)
|
15/10/2023 |
| 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="0"
Months="2"
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
|
The subjects who fulfilled the inclusion and exclusion criteria will be enrolled in the study. 11 Participants will be randomized into single arm.
Day 0: Baseline Medical history, physical examination, vitals ( weight, height,temperature) and Blood parameters will be monitored (CBC, FBS, PPBS, RFT, LFT, TFT, fluoride, CRP, Angiotensin converting enzyme level, Urine Routine ) and ECG
Day 1-7 : Patients will be on standard salt restricted diet as advised by the investigator. On day 8 Medical hiatory, physical examination, vitals ( weight, height, temperature) and Blood parameters will be monitored (CBC, FBS, PPBS, RFT, LFT. TFT, flouride, CRP, Angiotensin converting enzyme level, Urine Routine) and ECG
Day 7-14 De-NaPKC Foxtail millet with low salt first diose is instituted orally once daily in the morning insted of breakfast for 7 days. Normal Standard diet (salt restricted) will be followed for the rest of the meals for lunch and dinner.
Day 15: Medical examintaion , vitals and all blood parameters taken on screening will be monitored.
Primary Outcome
1) Adverse drug reaction 2) Safety Parameters 3) Nausea, Vomiting, Gastritis, ability to consume 350 ml, skin reaction, able to pass stool comfortably and event of hypoglycemic in diabetic patient, palpitation, hypersenetive or hyposenstive episodes, weight gain or loss |