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CTRI Number  CTRI/2021/07/034802 [Registered on: 13/07/2021] Trial Registered Prospectively
Last Modified On: 05/08/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical Study on the Health Benefits of TT Compounded Asafoetida Powder in Adults with Diabetes Mellitus Type II 
Scientific Title of Study   An Open Label, Prospective, Randomised, Comparative, Two Arm, Cohort Based, Two Stage Clinical Study To Evaluate The Effectiveness, Safety And Health Benefits associated with the everyday consumption of "TT Compounded Asafoetida Powder" of Mahesh Value Products Pvt. Ltd. In Adult Subjects With Diabetes Mellitus Type II 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
AHC/DM2/070/21 Version 01 29-May-21  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr VT Sriraam 
Designation  Investigator 
Affiliation  Aurous HealthCare Research and Development India Private Limited 
Address  180-109, G1 and G2, RR Villa, Rangarajapuram main road, Kodambakkam, Chennai, 600024.

Chennai
TAMIL NADU
600024
India 
Phone  9840909155  
Fax    
Email  md@auroushealthcare.com  
 
Details of Contact Person
Scientific Query  
Name  Dr VT Sriraam 
Designation  Investigator 
Affiliation  Aurous HealthCare Research and Development India Private Limited 
Address  180-109, G1 and G2, RR Villa, Rangarajapuram main road, Kodambakkam, Chennai, 600024.


TAMIL NADU
600024
India 
Phone  9840909155  
Fax    
Email  md@auroushealthcare.com  
 
Details of Contact Person
Public Query  
Name  Dr VT Sriraam 
Designation  Investigator 
Affiliation  Aurous HealthCare Research and Development India Private Limited 
Address  180-109, G1 and G2, RR Villa, Rangarajapuram main road, Kodambakkam, Chennai, 600024.


TAMIL NADU
600024
India 
Phone  9840909155  
Fax    
Email  md@auroushealthcare.com  
 
Source of Monetary or Material Support  
Mahesh Value Products Pvt.Ltd, 68 IV Floor C.P. Ramasamy Road, Alwarpet, Chennai 600018, Tamil Nadu. India.  
 
Primary Sponsor  
Name  Mahesh Value Products PvtLtd 
Address  68 IV Floor C.P. Ramasamy Road, Alwarpet, Chennai 600018, Tamil Nadu. India.  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Aurous HealthCare Research and Development India Private Limited  180-109, G1 and G2, RR Villa, Rangarajapuram main road, Kodambakkam, Chennai, 600024. 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr VT Sriraam  Raam Clinic  Room No 1, Department of General/Family Medicine, 180-109, G1 and G2, RR Villa, Rangarajapuram main road, Kodambakkam, Chennai, 600024.
Chennai
TAMIL NADU 		 9840909155

md@auroushealthcare.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Universal Ethics Committee (A Unit of Aurous HealtCare Research and Development India Pvt. Ltd )  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, (2) ICD-10 Condition:E785||Hyperlipidemia, unspecified. Ayurveda Condition: MEDOVRUDDHIH, (3) ICD-10 Condition:K297||Gastritis, unspecified. Ayurveda Condition: AMLAPITTAM, (4) ICD-10 Condition:K590||Constipation. Ayurveda Condition: MALAVRUTAVATAH, (5) ICD-10 Condition:I10||Essential (primary) hypertension. Ayurveda Condition: VATARAKTAJAVRANAH,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  TT Compounded Asafoetida Power  Dose 1g of TT Compounded Asafoetida Powder in 1 glass-approx 300ml-of buttermilk and consumed once a day Dosage : Once a day for 96 days Route of Administration : Oral Treatment Duration : 96 days  
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Must be prone to gastritis a minimum of 4 episodes per month
and must have had minimum one episode one week prior to screening. Subjects to score a total of Greater than or equal to 16 in the Amlapitta Symptoms Scale at screening.
5. Cohort 3-Constipation-Must be prone to constipation a minimum of 4 episodes per
month and must have had minimum one episode one week prior to screening. Subjects to score a total of Greater than or equal to 10 in the Constipation Severity Scale at screening.
6. Cohort 4-Hypertension-History of hypertension-systolic and or diastolic-a minimum of 3 months prior to screening. Must have elevated blood pressure-sitting, arm-at the time of screening.
7. Subjects who are on OHA or Insulin and or AYUSH remedies for the management of Diabetes Mellitus Type II
8. Subjects who willing to abstain from any remedies-allopathic, natural, home remedies-for relief or treatment of cohort indications.
9. Subjects who are willing to consume curd or buttermilk-animal and or plant milk-and are not lactose intolerant
10. Subject or LAR who is willing to give informed consent for participation, able to
comprehend and understand the responsibilities during treatment period and follow up period.
11. Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
 
 
ExclusionCriteria 
Details  1. Subjects with allergy, sensitivity or intolerance to the investigational product and or
the formulation ingredients.
2. Subjects on drugs, supplements, therapy regimens –Allopathic or AYUSH-that cause or propagate cohort conditions namely gastritis or constipation
3. Subjects with a history of significant cardiovascular disease-eg-congestive heart failure New York Heart Association Grade III or IV, arrhythmia known to increase the risk of thromboembolic events-eg, atrial fibrillation-, coronary artery stent placement, angioplasty, and coronary artery bypass grafting-Coronary artery bypass graft -CABG-, Percutaneous transluminal coronary angioplasty-PTCA-
4. Subjects who have clinically abnormal renal or hepatic function values that are 3x times normal upper limit or in the opinion of the Investigator would impact the objectives of the study.
5. Subjects with complete cancer remission less than 3 years prior to the date of screening.
6. Subjects with known history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases; except those that are considered etiology of said indication
7. Subjects who have undergone major surgical procedure 4 weeks prior to randomisation.
8. Subjects who are on anti-depressants, anti-psychotics.
9. Any significant medical condition -e.g., significant psychiatric or neurological disorders, active alcohol or drug abuse, etc.-any medical condition that is unstable or poorly controlled or other factor -e.g.-planned relocation-that the Investigator felt would interfere with study evaluations and study participation.
10. Subjects who have participated in any clinical study within 3 months from the date of enrolment.
11. Females who are pregnant or lactating or planning to become pregnant during the study period
12. Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
13. Subjects, who in the opinion of the Investigator are not eligible for enrolment in the study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Stage 1 Day 1to 48
FBG 10% reduction
PPG 10% reduction
HbA1C 10% reduction
Dyslipidemia 10% reduction
Amlapitta Symptoms Scale 25% reduction
Constipation Severity Scale 25% reduction
Hypertension : Improvement of 5 mmHg
Stage 2 Day 1to 96
FBG 125 mg/dL or 20% reduction
PPG 140 - 199 mg/dL or 20% reduction
HbA1C 6.4% A1C levels or 20% reduction
Dyslipidemia 20% reduction
Amlapitta Symptoms Scale Score of 8
Constipation Severity Scale Score of 5
Hypertension Normal BP 		 Stage 1 Day 1to 48
FBG Day 1, Day 48
PPG Day 1, Day 48
HbA1C Day 1, Day 48
Dyslipidemia Day 1, Day 48
Amlapitta Symptoms Scale Day 1, Day 48
Constipation Severity Scale Day 1, Day 48
Hypertension : Day 1, Day 48
Stage 2 Day 1to 96
FBG Day 1, Day 96
PPG Day 1, Day 96
HbA1C Day 1, Day 96
Dyslipidemia Day 1, Day 96
Amlapitta Symptoms Scale Day 1, Day 96
Constipation Severity Scale Day 1, Day 96
Hypertension Day 1, Day 96 
 
Secondary Outcome  
Outcome  TimePoints 
None  None 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "86"
Final Enrollment numbers achieved (India)="86" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/07/2021 
Date of Study Completion (India) 11/02/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="15" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

Study Design : An Open Label, Prospective,  Randomised, Comparative, Two Arm, Cohort Based, Two Stage Clinical Study

Indication : Diabetes Mellitus Type 2

Cohort 1- DM2 + Dyslipidemia

Cohort 2- DM2 + Gastritis

Cohort 3- DM2 + Constipation

Cohort 4- DM2 + Hypertension

Investigational Product : TT Compounded Asafoetida Powder

Comparator: Subjects who are to consume buttermilk without the Investigational Product to act as control subjects.

Dose/Dosage: 1g of  TT Compound Asafoetida powder to be consumed in a 300ml of butter milk, which is to be prepared as per the standardized instructions.

Subject Population : Adults aged between 30 and 65 years -both ages and all sexes inclusive-with history of uncomplicated Diabetes Mellitus type II with a minimum of one of the cohort conditions. Subject may have 1-4 cohort conditions mentioned but will be considered for only cohort for statistical analysis.

Number of Subjects :            

Stage 1 -20 Evaluable Subjects

Stage 2- 80 Evaluable Subjects

Treatment Arms:

Treatment Arm I – Test Subjects

Treatment Arm II – Control Subjects

Treatment Duration : 96 days per enrolled subject

Stage I : Interim analysis at Day 48

Stage II :  96 days per enrolled subject

Assessments

Fasting Blood Glucose- Day 0, Day 48, Day 96.

Post Prandial Blood Glucose- Day 0, Day 48, Day 96.

HbA1C- Day 0, Day 48, Day 96.

Dyslipidemia : Fasting Triglycerides :  Day 0, Day 48, Day 96.

Gastritis : Amlapitta Symptoms Scale Day 0, Day 48, Day 96.

Constipation : Constipation Severity Scale Day 0, Day 48, Day 96.

Hypertension- Day 0, Day 48, Day 96.

Background of the study:

Asafoetida is traditionally used for the treatment of different diseases, such as whooping cough, asthma, ulcer, epilepsy, stomachache, flatulence, bronchitis, intestinal parasites, antispasmodic, weak digestion and influenza. Asafoetida is an effective remedy for several diseases of the stomach. The digestive stimulant actions of asafoetida are the most commonly experimented beneficial physiological effect via enhanced secretion of saliva and activity of salivary amylase. It plays an important role in the digestion of dietary lipids by stimulating bile flow and enhances the bile acid secretion and also enhances the activities of digestive enzymes of the pancreas and small intestine. Moreover, it is used for low acid levels in the stomach, stomach pressure, flatulence and loose stools.

Purpose of the Study: This clinical study is designed in two stages. In the first stage, 20 evaluable subjects are  evaluated after a treatment period of 48 days (considered one mandalam of treatment as per AYUSH systems) : Interim Analysis.  Depending on the positive trend and results of  Stage I Clinical Study and the decision/discretion of the Sponsor, Stage II clinical study with 80 evaluable subjects (Stage I Subjects + 68 additional subjects) for a treatment period of 96 days is to be conducted.

Results of the Study :

DIABETES MELLITUS TYPE II

91.23% of subjects who consumed TT Compounded Asafoetida Powder showed ≥20% reduction in Fasting Blood Glucose in just 96 days. The average reduction  was 22.97% compared to 3.28% in Control Group.

89.47% of subjects who consumed TT Compounded Asafoetida  Powder showed ≥20% reduction in Post Prandial Glucose in just 96 days. The average reduction was 25.83% compared to 0.30% in  Control Group.

91.23% of subjects showed who consumed TT Compounded Asafoetida Powder ≥20% reduction in HbA1C in just 96 days. The average reduction was 21.39% compared to 0.88% in Control Group.

COHORT : DYSLIPIDEMIA  : TRIGLYCERIDES

The average reduction in Triglycerides was 22.32% in Subjects who consumed TT Compounded Asafoetida Powder in just 96 days, compared to 1.17% in the Control Group.

There was no statistically significant improvement seen in other Triglycerides – Cholesterol, LDL, HDL, VLDL in subjects of both treatment and control groups.

COHORT : GASTRITIS (AMLAPITTA SYMPTOMS SCORE)

81.25% of subjects who consumed TT Compounded Asafoetida Powder showed a statistically significant reduction in Gastritis as assessed by Amlapitta Symptoms Score in just 96 days, compared to Control Group, with a mean Total Score of 7.31 compared to 15.50 by Control Group

COHORT :  CONSTIPATION (CONSTIPATION SEVERITY SCALE)

92.85% of subjects who consumed TT Compounded Asafoetida Powder showed a statistically significant reduction in Constipation as assessed by Constipation Severity Scale in just 96 days, compared to Control Group, with a mean Total Score of 4.42 compared to 16.43 by Control Group

The mean reduction in Constipation Severity Scale used to assess Constipation was significantly higher compared to Control.

COHORT : HYPERTENSION

There was no statistically significant improvement seen in Hypertension in subjects of both treatment and control groups.

SAFETY AND TOLERABILITY

A total of 6 adverse events were reported in the clinical. 5 adverse events were reported in the treatment arm.

All adverse events were ruled not related to the investigational product.

No serious adverse event was reported in the study.

TT Compounded Asafoetida Powder is deemed safe for consumption.

USE OF STANDARD THERAPY

Subjects on a therapy regimen for Diabetes Mellitus Type II (OHA, Insulin, AYUSH products or combination thereof continued on the same throughout the treatment period along with the consumption of the Investigational product.

No changes were made to the existing therapy regimen for Diabetes Mellitus Type II during the treatment period.

No treatment was allowed not consumed for cohort indications – Dyslipidemia, Gastritis, Constipation and Hypertension.

CONCLUSION

Consumption of TT Compounded Asafoetida Powder with buttermilk significantly reduced Fasting Blood Glucose, HbA1C, Post Prandial Glucose in Subjects with Diabetic Mellitus Type II in 96 days.

Consumption of TT Compounded Asafoetida Powder with buttermilk significantly reduced Triglycerides in Subjects with Dyslipidemia in 96 days.

Consumption of TT Compounded Asafoetida Powder with buttermilk significantly reduced Gastritis in 96 days.

Consumption of TT Compounded Asafoetida Powder with buttermilk significantly reduced Constipation in 96 days.

 

Hence, upon statistical analysis of the clinical study, TT Compounded Asafoetida Powder is recommended as a safe, clinically verified and validated product to help reduce Blood Sugar Levels in Subjects with Diabetes Mellitus Type II, to significantly reduce Triglycerides, Gastritis and Constipation


 
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