CTRI

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CTRI Number

CTRI/2022/09/045501 [Registered on: 14/09/2022] Trial Registered Prospectively

Last Modified On:

23/07/2024

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Unani

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

A clinical study to evaluate the effect of a Unani Polyherbal formulation in the treatment of Diabetes Mellitus Type 2

Scientific Title of Study

A Randomised standard controlled clinical trial to evaluate the effect of a unani polyherbal formulation on ziabetus sukri qism doem (Diabetes Mellitus Type 2)

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Khan Qasim Bilal
Designation	MD student
Affiliation	Ayurvedic and Unani Tibbia College Hospital.
Address	Department of Moalijat, OPD no. 04, Ayurvedic and Unani Tibbia College Hospital, Ajmal Khan Road, Karol Bagh, Central DELHI- 110005 India Central DELHI 110005 India
Phone	7006674419
Fax
Email	khanqasimbilal@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Rais Ur Rahman
Designation	Professor and Supervisor
Affiliation	Ayurvedic and Unani Tibbia College Hospital
Address	Department of Moalijat, OPD no. 04, Ayurvedic and Unani Tibbia College Hospital, Ajmal Khan Road, Karol Bagh, Central DELHI- 110005 India Central DELHI 110005 India
Phone	9313980776
Fax
Email	drrahman002@gmail.com

Details of Contact Person
Public Query

Name	Dr Khan Qasim Bilal
Designation	MD student
Affiliation	Ayurvedic and Unani Tibbia College Hospital
Address	Department of Moalijat, OPD no. 04, Ayurvedic and Unani Tibbia College Hospital, Ajmal Khan Road, Karol Bagh, Central DELHI- 110005 India Central DELHI 110005 India
Phone	7006674419
Fax
Email	khanqasimbilal@gmail.com

Source of Monetary or Material Support

Ayurvedic and Unani Tibbia College and Hospital, Karol Bagh, New Delhi-110005

Primary Sponsor

Name	Ayurvedic and Unani Tibbia College and Hospital
Address	Ayurvedic and Unani Tibbia College and Hospital
Type of Sponsor	Government medical college

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Khan Qasim Bilal	Ayurvedic and Unani Tibbia College Hospital	Department of Moalijat, Ayurvedic and Unani Tibbia College Hospital, Ajmal Khan Road, Karol Bagh Central DELHI	7006674419 khanqasimbilal@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Ayurvedic and Unani Tibbia College and hospital Institutional Ethics committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

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	Extract of Unani Polyherbal formulation {Kalonji (Nigella sativa), Darchini (Cinnamomum zeylanicum), Methi (Trigonella foenum graceum), Magz Tukhm-e-jamun (Syzygium cuminu), Zanjabeel (Zingiber officinale), Charaita Talkh (Andrographis paniculata), Inderjo shereen (Wrightia tinctoria) filled in capsule form.	2 Capsules of 500mg twice a day, orally for 13 weeks.
Comparator Agent	Metformin in Tablet form	1 Tablet of 500mg twice a day orally for 13 weeks

Inclusion Criteria

Age From	18.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	1.Patient with Fasting Blood sugar more than or equal to 126mg/dl, 2. Post prandial Blood sugar more than or equal to 200 mg/dl, 3. Random Blood sugar more than 200 mg/dl with clinical features of diabetes, 4. Patient with HbA1c more than or equal to 6.5, 5. Patient willing to participate in the study, sign the understood consent form and ready to follow the instructions

ExclusionCriteria

Details

1. Patient with a Fasting Blood sugar of more than 400 mg/dl,
2. Pregnant and lactating women,
3. Patient with Anaemia (Hb <10gm/dl),
4. Hepatic and Renal impairment,
5. Uncontrolled Infection (TB, UTI, etc.) 6. Malignancy or taking Chemotherapy,
7. Patient having Diabetes Insipidus,
Diabetes Mellitus Type 1, Cushings
syndrome and Acromegaly,
8. Patient taking any medication which
raises the blood sugar level e.g;
Steroids , Diuretics , Oral
contraceptive pills etc.

Method of Generating Random Sequence

Coin toss, Lottery, toss of dice, shuffling cards etc

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
1.Develop a safe, efficacious and cost-effective drug for Type 2 Diabetes Mellitus on scientific parameters. 2.Evaluate the hypoglycaemic control of Test drug for acheiving a safe range of blood sugar on HbA1c parameter. 3.Evaluate the efficacy of test drug in comparison to a standard hypoglycaemic agent.	1.Clinical examination and subjective evaluation would be done at baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks and 13 weeks. 2.To evaluate efficacy- Blood sugar (F and PP) at the baseline, 1 Month, 2 Months, 3 Months. HbA1c at baseline and 3 months. 3.To Evaluate safety- Haemogram, LFT and KFT at the baseline, 8th day and after 13 weeks.

Secondary Outcome

Outcome	TimePoints
Evaluate the effect of Test drug on Insulin resistance.	At the baseline, 1 month, 2 months and 3 months.

Target Sample Size

Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40"

Phase of Trial

Phase 2

Date of First Enrollment (India)

25/09/2022

Date of Study Completion (India)

Date Missing

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="1"
Months="6"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Completed

Publication Details
Modification(s)

Nil

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary
Modification(s)

This study is a randomised, parallel group, active controlled clinical trial to evaluate the efficacy and safety of the extract form of a Unani polyherbal formulation in the management of Type 2 Diabetes Mellitus by using modern scientific parameters and to compare its efficacy with a standard hypoglycaemic agent. The study will also be used to evaluate the effect of this formulation on Insulin resistance. Diabetes Mellitus has become a global problem despite advancement of modern science. Owing to its various complications, it is a leading cause of morbidity and mortality. Several anti-diabetic agents are being used such as Biguanides, sulphonylureas, meglitinides etc., but the long-term use of these drugs result in the development of various side effects like Hypoglycaemic episodes, aplastic and haemolytic anaemia, diarrhoea, nausea and lactic acidosis etc. Therefore, search for a safe and effective anti-diabetic drug is a thrust area of research in every system of medicine.

A large number of safe and effective single and compound Unani drugs have been described in the classical Unani literature but little work has been done to explore them on scientific parameters. A study on an anti-diabetic Unani Polyherbal formulation has already been done in the Department of Moalejat, A & U Tibbia College and Hospital, Karol Bagh, New Delhi. This formulation is composed of four Unani single drugs administered in powder form and around 30% reduction in blood glucose levels was achieved. In the proposed study, 3 more safe and potent anti-diabetic Unani drugs have been added to this formulation. The new formulation will be prepared in 50% hydro-alcoholic extract form. The purpose is to improve and augment the efficacy of the formula for the safe and better treatment of Diabetes mellitus.