To see the effect of two medicines namely Kutajadi kwatha and kadaradi kwatha in the disease diabetes

Phase 3

• Conditions: Health Condition 1: E119- Type 2 diabetes mellitus without complications

• Registration Number: CTRI/2022/04/041754
• Lead Sponsor: Ayurvedic and Unani Tibbia College Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 2 May 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1 Patients  of  either  sex  aged  between  20  to  65  years.

2 If  yes  in  any two  of  the  four:

A  Blood  sugar  â??fasting  >  100  and  <=  125  mg/dl.

B PP > 140 mg/dl and  <=199  mg/dl.

  Glycosylated  Haemoglobin  (HbA1c)  >  5.7%  and  <  6.4%.

C Subjects  having  classical  symptoms  of  diabetes  with  random glucose  levels  >=200mg/dl (<=250mg/dl)

3 Subjects  who  are  able  to  come  for  follow  up  on  fixed  visits  and  are  well  aware  about  the treatment  plan.(only  type  2  DM  patients)

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

Exclusion Criteria

1 Age below  20  and  above  65yrs.

2 Subject  on    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. ï??  Subjects  with  current  or  past  diagnosis  of  malignancy  (any  malignancy  diagnosis  in  last  five years).

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

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

8 Subjects  having  hypersensitivity  to  any  of  the  trial  drug.

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in subjective parameters <br/ ><br>1.  Prabhoota  mootrata  â??  Polyurea <br/ ><br>2.  Avila  mootrata  â??  Unclear  /  turbid  urine (excessive  urine) <br/ ><br>3.  Kshudhaadhikya  -Polyphagia(  excessive  hunger) <br/ ><br>4.  Pipasaadhikya  -Polydipsia  (excessive  thirst) <br/ ><br>5.  Daurbalya/Shram-  Exhaustion  /  tiredness <br/ ><br>6.  Suptaangta/Daha  -Polyneuritis  (numbness  /  tingling/  burning  of  soles) <br/ ><br>7.  Pindikodveshtana  -  Cramps  while  walking/calf  muscle  pain <br/ ><br>8.  Vibandh-  constipation <br/ ><br>9.  Swedadikya <br/ ><br>10.  Swapna  sukhaTimepoint: At baseline and after 12 weeksÂ

Secondary Outcome Measures

Name	Time	Method
Assessment will be done clinically on basis of improvement in objective parameters like <br/ ><br>1. Blood sugar fasting (in mg/dl) <br/ ><br>2. Blood sugar post prandial(in mg/dl) <br/ ><br>3. Glycosylated Haemoglobin (HbA1c in %)Timepoint: to be assessed at the beginning and at the end of the trial