| CTRI Number |
CTRI/2026/03/105791 [Registered on: 10/03/2026] Trial Registered Prospectively |
| Last Modified On: |
09/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of Kabab Chini (Piper cubeba) in Reducing Proteinuria Among Patients with Diabetic Kidney Disease |
|
Scientific Title of Study
|
Efficacy of Kabab Chini (Piper cubeba)on microalbuminuria in Diabetic Nephropathy -A Single-Blind Randomised Standard Controlled Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nabeela Khatoon |
| Designation |
MD Scholar (UNANI) |
| Affiliation |
AJMAL KHAN TIBBIYA COLLEGE |
| Address |
Department of Moalajat, Faculty Of Unani Medicine ,AKTCH,AMU Aligarh
UTTER PRADESH INDIA
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9919961377 |
| Fax |
|
| Email |
nabeelakhatoon94150@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
TANZEEL AHMAD |
| Designation |
PROFESSOR |
| Affiliation |
AJMAL KHAN TIBBIYA COLLEGE |
| Address |
Department of Moalajat, Faculty Of Unani Medicine ,AKTCH,AMU Aligarh
UTTER PRADESH INDIA
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9448123337 |
| Fax |
|
| Email |
tanzeel1967@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
TANZEEL AHMAD |
| Designation |
PROFESSOR |
| Affiliation |
AJMAL KHAN TIBBIYA COLLEGE |
| Address |
Department of Moalajat, Faculty Of Unani Medicine ,AKTCH,AMU Aligarh
UTTER PRADESH INDIA
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9448123337 |
| Fax |
|
| Email |
tanzeel1967@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Moalajat, Faculty Of Unani Medicine ,AKTCH,AMU Aligarh,U.P, India 202002 |
|
|
Primary Sponsor
|
| Name |
Dept Moalajat |
| Address |
AKTCH.Faculty of Unani Medicine,AMU,Aligarh,UP,India 202002 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| DrNabeela Khatoon |
Dr.Nabeela khatoon |
Department of Moalajat, Faculty Of Unani Medicine ,AKTCH,AMU Aligarh 202002
UTTER PRADESH INDIA
Aligarh
UTTAR PRADESH |
09919961377
nabeelakhatoon94150@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E112||Type 2 diabetes mellitus with kidney complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kabab chini 3gm of fine powder |
Kabab chini 3gm of fine powder once a day |
| Comparator Agent |
Telmisartan 40 mg |
Telmisartan 40 mg once a day |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age between 30 to70 years.
Diagnosed with type 2 DM(4 years) with nephropathy.
UACR 30-300 mg/g
eGFRgreater than 60
HbA1cgreater than6.5%
BP 130/80 maintained
Those who give written consent. |
|
| ExclusionCriteria |
| Details |
Taking potassium-sparing diuretics.
Severe anaemia, Hb less than 6 per cent
UTI.
Severe Cardiovascular and cerebrovascular disease
Other primary or secondary renal diseases (e.g., IgA nephropathy, membranous
nephropathy, or lupus nephritis).
Pregnant or lactating women, women intending to become pregnant, and women
not using appropriate contraceptive methods
Severe mental disorder
Other unstable elements, such as malignancy
Drug or Alcohol abuse.
Breastfeeding.
Drugs that could affect urinary protein or renal function, eg, ARB, SGL-2
inhibitor Ramipril, Nonsteroidal/anti-inflammatory drug, Immunosuppressive
drug. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary endpoint is the change in UACR from baseline to 12 weeks. |
The primary endpoint is the change in UACR from baseline to 12 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in S.Cr. and eGFR (CKD EPI-2021 creatinine equation) from baseline to
12 weeks.
• Change in FBG and 2-h postprandial plasma glucose (2-h PG) from baseline to
12 weeks.
• Change in HbA1c from baseline to week 12. |
S.Cr. and eGFR (CKD EPI-2021 creatinine equation) from baseline to
12 weeks.
FBG and 2-h postprandial plasma glucose (2-h PG) from baseline to
12 weeks.
HbA1c from baseline to week 12. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
02/04/2026 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Diabetic kidney disease is a common complication of diabetes mellitus and a major cause of chronic kidney disease and end stage renal disease worldwide. In India a large proportion of patients who progress to end stage renal disease have underlying diabetic kidney disease and chronic kidney disease is frequently seen in people with type 2 diabetes. The growing number of individuals with type 2 diabetes has led to an increase in diabetic kidney disease resulting in significant illness death and healthcare burden. Kabab Chini also known as Piper cubeba is a medicinal plant used in Unani medicine and is reported to have antioxidant anti inflammatory and blood glucose lowering properties. Experimental studies suggest that it may reduce oxidative stress and inflammation which are important factors in kidney damage due to diabetes. However clinical evidence regarding its role in diabetic nephropathy especially in reducing microalbuminuria as an early marker of kidney damage is limited. This study is designed to evaluate the efficacy and safety of Piper cubeba in reducing microalbuminuria in patients with diabetic nephropathy and to explore its potential as an additional therapy along with standard treatment. |