Comparative effect of fresh and dry Giloy (Guduchi) in the management of diabetes

Phase 2/3

Not yet recruiting

Conditions: Type 2 diabetes mellitus with unspecified complications,

Registration Number: CTRI/2020/09/028006

Lead Sponsor: All India Institute of Ayurveda

Brief Summary: INTRODUCTION -

Diabetes mellitus is a sovereign disease considered as one of the arch-enemies of mankind, resulting due to faulty diet and lifestyle. It is a group of metabolic disorders characterized by hyperglycemia caused by an absolute or relative deficiency of Insulin There are 3 main types of Diabetes mellitus - 1) Type-1 DM 2) Type-2 DM 3) Gestational DM. In Ayurveda texts, the characteristic features of "Madhumeha" shows remarked resemblance with the syndrome of Diabetes Mellitus -2 (Type-2 DM). *Madhumeha* is a *tridoshaja* *vyadhi*but our ancient scholars mainly emphasized on vitiation of *Kapha dosha, Medodusthi*and *Meda dhatwagni mandya*. For disintegrating the pathogenesis, there must be a single drug or a formulation at the level of *dhatwagni*and counteracting *Kapha dosha* and *Meda dhatu*.

*Guduchi* (*Tinospora cordifolia*) is having *Katu-Tikta-Kashaya Rasa, Laghu Guna, Ushna veerya* and *Tridoshaghna*activity which may help in the disintegration of the pathogenesis of *Madhumeha.*Again in *Madhumeha*, there is *Ojakshyaya (Oja* is equivalent to *Bala*) and *Guduchi*is having the property of *Balya* and *Rasayana*. Regarding the form in which *Guduchi* is used, classics of Ayurveda have advised using it in *"Ardra*" (fresh) form but in day to day practice unfortunately it is used in the *"Shushka"*form. Further, a few works have been reported towards evaluating the efficacy of the classically mentioned use of "*Ardra Guduchi*". Therefore, a clinical study to compare the anti-diabetic effect of *Tinospora cordifolia - ardra (*TCa*)*and*Tinospora cordifolia - shushka (*TCs*)*isplanned*.*

OBJECTIVES OF RESEARCH -

1. Primary objective - To assess clinically the comparative anti-diabetic activity of *Ardra*(TCa) and *Shushka* (TCs) *Guduchi*.

2. Secondary objectives - \* Analytical study (HPLC, HPTLC) of TCa and TCs.

\* Quality of Life (QOL) Assessment

METHODOLOGY -

1. Drug Identification - Certification from taxonomist and Dravyaguna specialist will be taken and a voucher specimen will be preserved.

2. Drug Analysis - Analysis of TCa and TCs in HPLC and HPTLC method.

3. Drug Preparation - The drugs are prepared in the college pharmacy or procured from any reputed pharmacy as suitable.

4. Study Design- Three Armed Randomised Standard Controlled Trial.

5. Sample Size = Total 60 ( 20 in each group)

6. Group - A (TCa + Lifestyle modification) - TCa Ghan (aqueous solid extract) tablets, at a dose of 500 mg twice a day orally after breakfast and supper with lukewarm water.

7. Group - B (TCs + Lifestyle modification) - TCs Ghan tablets, at a dose of 500 mg twice a day orally after breakfast and supper with lukewarm water.

8. Group - C (Standard control) (Glimepiride + Lifestyle modification + Placebo capsules of wheat powder) - Glimepiride (1mg) tablets and 1 placebo capsule once a day (or titrate as per blood glucose level) orally 15 minutes before breakfast with water.

9. Duration - 3 months

10. Purpose of the trial - The purpose of the trial is the same as the primary objective of the research i.e. to evaluate clinically the comparative antidiabetic activity of Ardra & Shushka Guduchi (TCa and TCs).

11. Findings if any - As the patient recruitment is not started yet henceforth the findings are going to be evaluated after completion of the study.

12. Publication details - After completion of the thesis work, the study will be published in peer-reviewed journals.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

Recently diagnosed (less than 1 year of diabetic history) cases of Type-2 DM and not taking any antidiabetic drug/Insulin since 2 months 2.
Including both Pre-diabetes and diabetes cases Fasting Blood Sugar (FBS) ranges between 100 to 125 mg/dl in pre-diabetes and greater than 126 mg/dl to less than equal to 200 mg/dl in diabetes cases.
Post Prandial Blood Sugar (PPBS) ranges between 140 to 199 mg/dl in Pre-diabetes and greater than 200 mg/dl to less than equal to 350 mg/dl in diabetes cases.
HbA1c ranges between 5.7 % to 6.4 % in Pre-diabetes and greater than equal to 6.5 % to less than equal to 8 % in diabetes cases.
Presence of urine sugar 4.
Frequency of urination 7 to 10 times per 24 hours and quantity and quantity greater than equal to 2500 ml 5.
Accidentally diagnosed cases of Type-2 DM who visit the hospital for other complaints.

Exclusion Criteria

Cardiovascular disorder with Type-2 DM 2.
Malignant and accelerated Hypertensive 3.
Pregnant woman and planning to be pregnant within 6 months 4.
Lactating mother 5.
Secondary Diabetes Mellitus 6.
Patients undergoing regular treatment for diabetes or any other severe illness 7.
CNS Disorder e.g. Encephalopathy 8.
Subjects already suffering from the complications of Diabetes (Diabetes Nephropathy, Diabetic retinopathy, Diabetic Neuropathy etc.) 9.
Poorly controlled Glycemic status (HbA1c greater than 8%) 10.
Concurrent serious hepatic dysfunction (AST or ALT greater than 3 times of upper normal limit) 11.
Subjects on steroids, oral contraceptives or estrogen replacement therapy 12.
Hypothyroidism or hyperthyroidism 15.
Patients under other clinical trials for more than 12 weeks.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To access clinically the comparative anti-diabetic activity of Aardra (TCa) and Shushka (TCs) Guduchi by assessing the blood glucose level and HbA1c level	1. Blood Glucose level - 0th day, 15 th day, 30th day, 45 th day, 60 th day, 75 th day, 90th day \| 2. HbA1c level - 0th day and 90th day

Secondary Outcome Measures

Name	Time	Method
1. Analytical study (HPLC, HPTLC) of TCa and TCs	2. Quality of Life assessment.

Trial Locations

Locations (1): All India Institute of Ayurveda
🇮🇳
South, DELHI, India
All India Institute of Ayurveda
🇮🇳South, DELHI, India
Dr Niranjan Ram
Principal investigator
07978796914
vaidyaniranjanram@gmail.com
Prof Dr Tanuja Manoj Nesari
Principal investigator
9958817145
tnesari@hotmail.com