effect of bhallataka on diabetes

Phase 1/2

Recruiting

• Conditions: Patients suffering from Diabetes

• Registration Number: CTRI/2013/04/003544
• Lead Sponsor: IPGT and RA

Brief Summary

randomized double blind clinical trials oftwo different samples of *Bhallataka Kshaudra*will be carried out on the patients of *Madhumeha*(NIDDM) very cautiously as per classics.

Plan of study:

Criteria for selection of patients:

Patients having classical symptomatology of *Madhumeha* (NIDDM) will be selected fromO.P.D. and I.P.D. of I.P.G.T. and R.A., Hospital, Jamnagar.

·        Age group of patients will be between 18 to 75years.

·        Patients having fasting blood sugar level≥126mg/dlor 2hrs.

·        Post prandial glucose level≥200mg/dl up to 600mg/dlwill be selected from O.P.D and I.P.D of I.P.G.T. and R.A., Hospital, Jamnagar.

Criteria for exclusion of Patients:

(A) Patients of Diabetes mellitus receiving Insulin.

(B) Patients having chronic complications ofDiabetes mellitus

a.       Microvascular:Retinopathy, Neuropathy and Nephropathy.

b.      Macrovascular:Coronary artery disease, Peripheral vascular disease & Cerebro-vasculardisease.

c.       Other chronicdebilitating disease like STD etc.

(C) *Pitta-Adhikya,Garbhini, Vimukta Raktatva, Trisna, Mukha Shosha, Anatamvana, Aalsi, Pramadi,Vyasani, Bhesajapmani*.

Criteria for diagnosis of Diabetes mellitus (NIDDM)

·        Symptoms of Diabetes (Polyuria, Polydipsia &Polyphagia and weight loss)

·        Fasting Plasma glucose ≥126mg/dl.

·        Two hour Plasma glucose ≥200mg/dl during an oralglucose tolerance test.

A detailed proforma will be prepared, alsowith detailed history will be taken and complete physical examination will becarried out to assertion the diagnosis. Laboratory investigations like plasmaglucose level, s-cholesterol, Heamatological (Hb, TLC, DLC, ESR), Urine(routine, microscopic), Biochemical (BSL, LFT, RFT, Lipid profile,s-creatinine) and if needed special investigations like plasma Insulin, GlycosylatedHaemoglobin etc. will also be carried out as per availability.

Groups:

Selected patients will be divided into two groups –

(1)  Group A – In this group,patients will be treated with drug prepared with *Yava Rashi Nidhapita Bhallataka*.

(2)  Group B – In this group,patients will be treated with drug prepared with *Yava Rashi* Anidhapita*Bhallataka*.

Posology;

Dose                :500 mg in divided dose inboth the groups.

Duration         : 4 weeks

Follow up       : Patients will be reviewed after 7 days for a periodof 4 weeks.

**Assessment of overall effect of the therapy:** Forthe assessment of the effect of the therapy following criteria will be used –

(1)  Improvement of the signs and symptoms of the disease asper Ayurvedic and Modern classics.

(2)  All the required investigations will be conductedbefore and after the management of the patient.

 (3)  **A scoring pattern will be used – 100 points will bedivided as follows:**

·        Subjective criteria                    – 50 points

·        Objective criteria                     – BSL-F          –25 points

– BSL-PP        – 25 points

**Scoring for biochemical parameters; Blood sugar level –**

80%to 90% Improvement                                    –25 points

60%to 80% Improvement                                    –20 points

40%to 60% Improvement                                    –15 points

20%to 40% Improvement                                    –10 points

**<**20% Improvement                                    –05 points

No Improvement                                    – 00 points

(4)  **Theresult obtained from individual patients will be categorized as –**

·        Control of the disease                               – 100% relief

·        Marked improvement                                - â‰¥75% relief

·        Moderate improvement                             – 50% upto 75% relief

·        Mild improvement                                    -≥25% upto 50% relief

·        No improvement                                       -<25% relief

Statistical analysis:

Mean, percentage relief, SD, SE, ‘t’and ‘p’ values will be calculated. Paired ‘t’ test will be used for calculatingthe ‘t’ value in the paired data. For comparison of the results with normalcontrol group, unpaired ‘t’ test will be used. For comparison of results inobjective parameters, “Analysis of Variance Test (ANOVA)†will be applied.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-21
• Last Update Posted: 2013-08-29

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• •Patients having fasting blood sugar level≥126mg/dl or 2hrs.
• •Post prandial glucose level≥200mg/dl up to 600mg/dl.

Exclusion Criteria

• (A) Patients of Diabetes mellitus receiving Insulin.
• (B) Patients having chronic complications of Diabetes mellitus a.Microvascular: Retinopathy, Neuropathy and Nephropathy.
• b.Macrovascular: Coronary artery disease, Peripheral vascular disease & Cerebro-vascular disease.
• c.Other chronic debilitating disease like STD etc.
• (C) Pitta-Adhikya, Garbhini, Vimukta Raktatva, Trisna, Mukha Shosha, Anatamvana, Aalsi, Pramadi, Vyasani, Bhesajapmani.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•Symptoms of Diabetes (Polyuria, Polydipsia & Polyphagia and weight loss)	28 days
•Fasting Plasma glucose ≥126mg/dl.	28 days
•Two hour Plasma glucose ≥200mg/dl during an oral glucose tolerance test.	28 days

Secondary Outcome Measures

Name	Time	Method
exacerbation in signs and symptoms	4 weeks

Trial Locations

Locations (1)

OPD and IPD Hospital IPGT and RA; 🇮🇳 Jamnagar, GUJARAT, India

OPD and IPD Hospital IPGT and RA

🇮🇳Jamnagar, GUJARAT, India

Prof PK Prajapati

Principal investigator

9428315733

prajapati.pradeep1@gmail.com