A Comparative Study of the Effect of Ayurvedic Drugs and Metformin in the Management of Diabetes Mellitus (Type II)

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Comparative Study of the Effect of "Chhinnavahni Kashaya Vati" Along With "Agnimantha Kwatha" & Metformin in the Management of Madhumeha w.s.r. to Diabetes Mellitus (Type II)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05451147
• Other study ID #: N.F.5(283)/2013-CO
• Status: Completed
• Phase: Phase 3
• Start date: September 3, 2018
• Est. completion date: April 30, 2019

Study information

• Verified date: July 2022
• Source: A & U Tibbia College Karol Bagh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Present study entitled "A Comparative Study of the Effect of "Chhinnavahni Kashaya Vati" along with "Agnimantha Kwatha" & Metformin in the management of Madhumeha w.s.r. to Diabetes mellitus (Type II)" is a small effort to find out an effective remedy for Madhumeha i.e. Diabetes Mellitus Type-2

Description:

Single centered, randomized clinical trial of Chhinnavahni Kashaya Vati along with Agnimantha Kwatha was carried out on total of 60 registered patients. They were randomly classified in two groups, where in Group-A received Chhinnavahni Kashaya Vati with Agnimantha Kwatha and Group-B received Metformin for 12 weeks. Out of these, 12 patients did not complete the full course of the treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Patients of either sex aged between 20 to 60 years.

2. If yes in any two of the four:

• Blood sugar -fasting > 126 and = 250 mg/dl.

• PP > 200 mg/dl and =350 mg/dl.

• Glycosylated Haemoglobin (HbA1c) > 6.5% and < 9%.

• Subjects having classical symptoms of diabetes with random glucose levels =200mg/dl (=350mg/dl).

3. Diagnosed cases of Type II Diabetics having Glycosylated Haemoglobin (HbA1c) between 6.5-9% without or {with metformin in a dose1g-1.5g/day (for Group-B)}.

4. Subjects who are able to come for follow up on fixed visits and are well aware about the treatment plan.

5. Subjects willing to participate and able to provide written informed consent.

Exclusion Criteria:

1. Age below 20 and above 60yrs.

2. Subject of Type-I DM (insulin dependent DM) or Type-II DM on insulin/OHA's other than metformin/ any other AYUSH medication for glucose control.

3. Subjects suffering from the complications of Diabetes mellitus viz., diabetic neuropathy, diabetic nephropathy, diabetic retinopathy etc. which require an urgent treatment.

4. Uncontrolled Hypertensive subjects (BP with or without medication >140/90 mmHg after 5 mins of rest).

5. Subjects with any unstable Heart disease or known cases of MI, unstable angina or CHF.

6. Patients with concurrent Hepatic Dysfunction (defined as AST and/or ALT > 2 times of the upper normal limit) or Renal Dysfunction, uncontrolled Pulmonary Dysfunction (asthmatic and COPD subjects).

7. Subjects with current or past diagnosis of malignancy (any malignancy diagnosis in last five years).

8. Subjects who have a recent history or who are currently known to abuse of alcohol or drugs.

9. Subjects suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, TB, AIDS etc).

10. Female subject of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception during the study therapy and for 4 weeks after the end of study therapy.

11. Pregnant / Lactating women.

12. Subject on systemic or oral steroids, oral contraceptive pills or estrogen replacement therapy.

13. Subjects having hypersensitivity to any of the trial drug.

14. Subjects who have completed participation in any other clinical trial during the past six (06) months.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Chhinnavahni Kashaya Vati along with Agnimantha Kwatha
Drug: Chhinnavahni Kashaya Vati Form : Tablet Dose: 1g TDS (2x500 mg), Before meals Mode of Administration: Oral Anupaan: 20 ml of Agnimantha Kwatha Duration: 3 Months
• Metformin Hydrochloride
Drug: Metformin Form: Tablet Dose: 500mg BID/TDS, Before meals Mode of Administration: Oral Anupaan: Plain water Duration: 3 Months

Locations

Country	Name	City	State
India	A and U Tibbia College	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
A & U Tibbia College Karol Bagh

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OBJECTIVE PARAMETERS	1. Blood sugar fasting in Milligrams per decilitre	Change from Baseline at End of trial [3 month]
Primary	OBJECTIVE PARAMETERS	Blood sugar post prandial Milligrams per decilitre	Change from Baseline at End of trial [3 month]
Primary	OBJECTIVE PARAMETERS	Glycosylated Haemoglobin (HbA1c in %)	Change from Baseline at End of trial [3 month]
Secondary	SUBJECTIVE PARAMETERS	Polyurea (excessive urine) grading from 0 to 3	Change from Baseline at End of trial [3 month]
Secondary	SUBJECTIVE PARAMETERS	Unclear / turbid urine grading from 0 to 3	Change from Baseline at End of trial [3 month]
Secondary	SUBJECTIVE PARAMETERS	Polyphagia( excessive hunger) grading from 0 to 3	Change from Baseline at End of trial [3 month]
Secondary	SUBJECTIVE PARAMETERS	Polydipsia (excessive thirst) grading from 0 to 3	Change from Baseline at End of trial [3 month]
Secondary	SUBJECTIVE PARAMETERS	Exhaustion / tiredness grading from 0 to 3	Change from Baseline at End of trial [3 month]
Secondary	SUBJECTIVE PARAMETERS	Polyneuritis (numbness / tingling/ burning of soles) grading from 0 to 3	Change from Baseline at End of trial [3 month]
Secondary	SUBJECTIVE PARAMETERS	Cramps while walking/calf muscle pain grading from 0 to 3	Change from Baseline at End of trial [3 month]
Secondary	SUBJECTIVE PARAMETERS	Constipation grading from 0 to 3	Change from Baseline at End of trial [3 month]
Secondary	SUBJECTIVE PARAMETERS	Excessive Sweating grading from 0 to 3	Change from Baseline at End of trial [3 month]
Secondary	SUBJECTIVE PARAMETERS	Excessive Sleeping grading from 0 to 3	Change from Baseline at End of trial [3 month]
Secondary	SUBJECTIVE PARAMETERS	DSQ grading from 0 to 3	Change from Baseline at End of trial [3 month]