Effect of Triphaladi granules and Rohitakadi churna in Diabetes Mellitus Type 2

Phase 4

Completed

• Conditions: Type 2 diabetes mellitus without complications,

• Registration Number: CTRI/2020/03/023876
• Lead Sponsor: All India Institute of Ayurveda

Brief Summary

**INTRODUCTION:** Diabetes mellitus is a chronic diseasecaused by inherited and/or acquired deficiency in production of insulin by thepancreas, or by the ineffectiveness of the insulin produced. Such a deficiencyresults in increased concentrations of glucose in the blood, which in turndamage many of the body’s systems, in particular the blood vessels and nerves. The diseases afflicting urine are classified intotwo types *Mutra Apravrittaja Rogas*i.e. diseases leading to less quantity of urine and *Mutratipravrittaja Rogas* i.e. diseases leading to excess quantityof urine, *Prameha* being *Mutratipravrittaja roga. Prameha* as theword says, “*prakarshena prabhutamprachuram varam varam va mehatiâ€.* It is further subdivided into20, based on physical abnormalities of urine. However, all *Prameha* if neglected may lead to *Madhumeha* in long term.*Madhumeha* has been extensively described inancient *ayurvedic* texts of all timesincluding *brihadtrayi and laghutrayi.* *AcharyaCharaka* is very specific whiledescribing the types of Prameha on the basis of onset as *Sahaja* / *JatahPrameha* and *Apathyanimittaja* *prameha.*

**AIMS and OBJECTIVES**

**AIMS:**

To provide DMT2 patients with thepossibilities of

(i) Reduction in BSL

(ii)  Improving quality of life in DMT2 patients.

**OBJECTIVES:**

The objectives of conducting thisstudy are:

PRIMARY OBJECTIVES:

To determine the efficacy of *yakrit-uttejaka* ***rohitakadi churna*** along with ***triphaladi granules*** *over* that of ***triphaladi granules*** alone in the management of *madhumeha* by estimating the levels of FBS,PPBS, HbA1C.

        SECONDARY OBJECTIVES:

1. To determine the Quality of Life inDMT2

2. To evaluate the pharmacognostical potencyof the trial drug

3. To evaluatein terms of *Ayurveda*parameters, such as *roga bala, agnibala, deha bala, chetas          balaand mutra pariksha.*

4. Todetermine the Urine sugar concentration bycolorimetric assessment

 **EXECUTIONOF THE PROPOSED CLINICAL STUDY**

TYPE OF STUDY DESIGN: Randomised ComparativeClinical Trial

SETTING:  The OPDs’ and IPD’s of AIIA

RESEARCH DESIGN: Interventionalstudy

ALLIGNMENT: Parallel

SAMPLE: population- Patients from institutionalhospital

SAMPLING METHOD: Computer generated table

MASKING: open label

SAMPLE CLASSIFICATION:

Group A: ***Triphaladi granules***

Group B : ***Triphaladi granules + Rohitakadi churna***

**POSOLOGY:**

| | | |

| --- | --- | --- |

| **Group A**

**Group B**

|**Drug**

Triphaladi granules

Triphaladi granules + Rohitakadi churna

|**Form**

Powder

Powder

|**Dose**

5gm morning after breakfast and night before meal daily

5gm each morning after breakfast and night before meal daily

|**Mode of administration**

Oral

Oral

|**Anupaan**

Plain water

Plain water

|**Duration**

3 months

3 months

 **DIET AND EXERCISE (COMMON TO BOTHGROUPS)** **:**

In Ayurvedic treatment, the maintreatment regime includes drug intake along with the *pathya-apathya* in *ahara-vihara*and physical activities.

The patients would be advised tofollow particular diet and exercises explained to them in detailed proformas.

**DURATION OF THE TRIAL****:** 3 MONTHS with a follow up periodof 1 month

Detail Timeline of the Proposed ResearchProject are listed in annexure

**MONITORINGPERIOD 0 – 3M:**

Patients are told to report weeklyfor 1st 2 weeks and then fortnightly during the period of next threemonths. At the end of monitoring period, the drugs will be withdrawn.

**FOLLOWUP PERIOD: 3M-4M**

Patients are informed to reportafter 1 month of completion of clinical trial (window period of 7 days)

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-24
• Last Update Posted: 2021-03-03

Recruitment & Eligibility

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

Inclusion Criteria

• Patients of either gender in the age group of 25 to 65 years 2.
• Patients with classical signs and symptoms of Prameh or Madhumeha viz Prabhuta Mutrata Avila Mutrata Pipasadhikya Alasya Utsahahani Kshudhadhikya Pindikodveshthana Karapadatala Suptata Daurbalya Nidradhikya and Purishabadhdhata.
• Inclusion criteria based on blood investigations Fasting blood sugar FBS less than 140 mg per dl up to 200 mg per dl and Patients with random blood sugar level RBS more than 200 mg per dl upto 350 or Postprandial blood sugar PPBS more than 200 mg per dl up to 350 mg per dl and Glycosylated haemoglobin more than 6.5 percent upto 10 percent 4.
• Newly or early diagnosed cases to be included as per following criteria Patients who are not taking any conventional medicine for more than two months whose sugar levels are raised and fall within the inclusive criteria mentioned above and are willing to take Ayurvedic treatment Patient accidently diagnosed in routine checkup or when appeared with other complaints in the hospital.
• Early diagnosed diabetic patients less than 2yr of diabetic history and not taking any pharmacological drugs since last two months.
• Frequency of urination 7 to 10 times per 24 hours or quantity equal or more than 2500ml per 24 hours 6.
• Presence of urine sugar.

Exclusion Criteria

• Patients with acute or chronic liver disease with elevated liver enzymes.
• Patients with history of alcohol abuse.
• Patients having insulin dependent DM type 1 and receiving insulin 4.
• Chronic complications like microvascular and macrovascular derangements.
• Hyper or hypothyroidism 6.
• Patients reporting to be hypersensitive to any of the proposed trial drugs.
• Patients on vitamin B supplementation, NSAIDs. 8.
• Pregnant women or lactating mothers 9.
• Participation in other clinical studies in past 12 weeks.
• Takes psychotropic medications that raise blood glucose e.g. atypical antipsychotics.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2.Blood sugar fasting post prandial random in mg/dl	on 0th day and on 91st day
1.Glycosylated haemoglobin in % percent	on 0th day and on 91st day

Secondary Outcome Measures

Name	Time	Method
1. Quality of Life in DMT2	2. Ayurveda parameters such as roga bala agni bala deha bala chetas bala and mutra pariksha 24 hour Quantity of urine

Trial Locations

Locations (1)

All India Institute of Ayurveda; 🇮🇳 West, DELHI, India

All India Institute of Ayurveda

🇮🇳West, DELHI, India

Dr Mythri H S

Principal investigator

9448727127

drmythri.achar@gmail.com