| CTRI Number |
CTRI/2023/04/051394 [Registered on: 10/04/2023] Trial Registered Prospectively |
| Last Modified On: |
17/10/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Multicentric clinical trial to treat immune deficiency patients with Manda Koso. |
|
Scientific Title of Study
|
A Multicentric, Randomized, Double Blind, Parallel Group, Two Arm, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Manda Koso versus Placebo in patients with immune deficiency. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol ID: MCR/CT/1222/07 |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vaishal Shah |
| Designation |
Principle Investigator |
| Affiliation |
Lifeline Multispeciality Hospital |
| Address |
Lifeline Multispeciality Hospital, Vishal Complex, S.V.Road, Opp. N.L. High School, Malad (West), Mumbai – 400 064.
Mumbai
MAHARASHTRA
400064
India |
| Phone |
9833803296 |
| Fax |
|
| Email |
vshah8962@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravindra Mote |
| Designation |
Director |
| Affiliation |
Mediclin Clinical Research |
| Address |
Mediclin Clinical Research, 2nd Floor, Ritu Horizon, Next to Ankur School, Kanakiya Road, Mira Road (E), Thane- 401 107.
Thane
MAHARASHTRA
401107
India |
| Phone |
8888884024 |
| Fax |
|
| Email |
ravindra.mote@mediclincr.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Milind Gharpure |
| Designation |
General Manager-Natural Product |
| Affiliation |
ThinQ Pharma-CRO Ltd. |
| Address |
THINQ House, A-30, Road No. 10, MIDC, Wagle Estate, Thane – 400604.
Thane
MAHARASHTRA
400604
India |
| Phone |
02225816800 |
| Fax |
|
| Email |
milind@thinqcro.com |
|
|
Source of Monetary or Material Support
|
| ThinQ Pharma-CRO Ltd. AND Manda Fermentation Co., Ltd. |
|
|
Primary Sponsor
|
| Name |
ThinQ Pharma-CRO Ltd. |
| Address |
THINQ House, A-30, Road No. 10, MIDC, Wagle Estate, Thane – 400604. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Manda Fermentation Co Ltd |
5800-95 Innoshima Shigeicho, Onomichi City, Hiroshima Pref., Japan 722-2192. |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dnyaneshwar Halnor |
Family Care Hospital |
PK Road, Opp. Seven Square Academy, Mira Road (E), Maharashtra-401107
Thane
MAHARASHTRA |
7507779219
drhalnordnyaneshwar@gmail.com |
| Dr Rakesh Patil |
KKasturi Medicare Pvt. Ltd. |
Harshniketan, Gaondevi Road, Behind Navrang Hotel, Bhayandar West, Thane – 401101
Thane
MAHARASHTRA |
9867252877
drrakeshpatil07@gmail.com |
| Dr Vaishal Shah |
Lifeline Multispeciality Hospital |
Vishal Complex, S.V.Road, Opp. N.L. High School, Malad (West), Mumbai – 400 064.
Mumbai
MAHARASHTRA |
9833803296
vshah8962@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Ethicare Ethics Committee |
Approved |
| Shah Lifeline Hospital And Heart Institute Ethics Committee |
Approved |
| Shah Lifeline Hospital And Heart Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D849||Immunodeficiency, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Manda Koso |
One sachet of Manda Koso twice a day around same time for 90 days |
| Comparator Agent |
Placeo |
One sachet of Placebo twice a day around same time for 90 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female patients aged between 18 and 65 years (both inclusive).
2. Subjects with CD4 count 300 to 700 cells per cubic millimeter.
3. Subjects with (Immune Status Questionnaire) ISQ Score is ≤ 6.
4. Subjects with Non-alcoholic grade -I Cirrhosis OR Latent TB OR Hypothyroidism OR HIV will be included in the study.
OR
Subjects with history of Non-alcoholic grade - I Cirrhosis OR Controlled Type 2 DM OR Latent TB OR Hypothyroidism OR HIV for at least 2 months will be included.
5. Written, signed and dated informed consent obtained from patients before performing any study related procedures.
6. Subjects willing to comply with the protocol requirements. |
|
| ExclusionCriteria |
| Details |
1. Subjects having history of hypersensitivity to any of components of the formulation.
2. Subjects having history of allergy to any of soy, sesame and walnut or other components of the formulation.
3. Subjects with history of uncontrolled diabetes mellitus, unstable angina pectoris, and myocardial infarction (MI).
4. Subjects with HbA1c ≥ 8%.
5. Subjects with AIDS.
6. Subjects taking steroid treatment.
7. Subjects with terminal illness.
8. Women of childbearing potential if pregnant (test positive for pregnancy) at screening visit, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
9. Subjects participating in any other clinical study or having participated in any other study 3 months prior to screening in the present study.
10. Other conditions, which in the opinion of the investigators makes the patient unsuitable for enrolment or could interfere in adherence to of the study protocol. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in CD4, CD8 count, CD4:CD8 ratio from baseline to end of the study visit. |
Mean change in CD4, CD8 count, CD4:CD8 ratio from week 1 to week 13. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Mean change in interferons gamma from baseline to end of the study visit.
2. Mean change in Interleukins-12 from baseline to end of the study visit.
3. Mean change in Quality of life (QoL) score from baseline to end of the study visit. |
1. Mean change in interferons gamma from week 1 to week 13.
2. Mean change in Interleukins-12 from week 1 to week 13.
3. Mean change in Quality of life (QoL) score from week 1 to week 13. |
|
Target Sample Size
Modification(s)
|
Total Sample Size="78"
Sample Size from India="78"
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 |
|
Date of First Enrollment (India)
|
13/04/2023 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A Multicentric, Randomized, Double Blind, Parallel Group, Two Arm, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Manda Koso versus Placebo in patients with immune deficiency. |