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

Phase 2

Completed

• Conditions: Type 2 diabetes mellitus without complications,

• Registration Number: CTRI/2022/09/045501
• Lead Sponsor: Ayurvedic and Unani Tibbia College and Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-25
• Last Update Posted: 2024-07-23

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Develop a safe, efficacious	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.
and cost-effective drug for	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.
Type 2 Diabetes Mellitus on	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.
control of Test drug for	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.
acheiving a safe range of	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.
blood sugar on HbA1c	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.
parameter.	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.
3.Evaluate the efficacy of	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.
test drug in comparison to	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.
a standard hypoglycaemic	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.
scientific parameters.	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.
2.Evaluate the hypoglycaemic	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.
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 Measures

Name	Time	Method
Evaluate the effect of Test drug on Insulin resistance.	At the baseline, 1 month, 2 months and 3 months.

Trial Locations

Locations (1)

Ayurvedic and Unani Tibbia College Hospital; 🇮🇳 Central, DELHI, India

Ayurvedic and Unani Tibbia College Hospital

🇮🇳Central, DELHI, India

Dr Khan Qasim Bilal

Principal investigator

7006674419

khanqasimbilal@gmail.com