Clinical Study on the Health Benefits of TT Compounded Asafoetida Powder in Adults with Diabetes Mellitus Type II
- Conditions
- 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,
- Registration Number
- CTRI/2021/07/034802
- Lead Sponsor
- Mahesh Value Products PvtLtd
- Brief Summary
**Study Design :** An Open Label, Prospective, Randomised, Comparative, Two Arm, Cohort Based, Two Stage Clinical Study
**Indication :** DiabetesMellitus 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 toact as control subjects.
**Dose/Dosage:** 1gof TT Compound Asafoetida powder to be consumedin a 300ml of butter milk, which is to be prepared as per the standardizedinstructions.
**Subject Population** : Adults aged between 30 and 65 years -both ages and all sexesinclusive-with history of uncomplicated Diabetes Mellitus type II with aminimum of one of the cohort conditions. Subject may have 1-4 cohort conditionsmentioned 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 :** Interimanalysis 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 SeverityScale** Day 0, Day 48, Day 96.
**Hypertension**-Day 0, Day 48, Day 96.
**Background of the study:**
Asafoetida is traditionally used for thetreatment of different diseases, such as whooping cough, asthma, ulcer,epilepsy, stomachache, flatulence, bronchitis, intestinal parasites,antispasmodic, weak digestion and influenza. Asafoetida is an effective remedyfor several diseases of the stomach. The digestive stimulant actions ofasafoetida are the most commonly experimented beneficial physiological effectvia enhanced secretion of saliva and activity of salivary amylase. It plays animportant role in the digestion of dietary lipids by stimulating bile flow andenhances the bile acid secretion and also enhances the activities of digestiveenzymes of the pancreas and small intestine. Moreover, it is used for low acidlevels 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 evaluatedafter a treatment period of 48 days (considered one mandalam of treatment asper AYUSH systems) : Interim Analysis. Depending on the positive trend and results of Stage I Clinical Study and thedecision/discretion of the Sponsor, Stage II clinical study with 80 evaluablesubjects (Stage I Subjects + 68 additional subjects) for a treatment period of96 days is to be conducted.
**Results of the Study :**
**DIABETES MELLITUS TYPE II**
91.23% of subjects who consumed TTCompounded Asafoetida Powder showed ≥20% reduction in Fasting Blood Glucose injust 96 days. The average reduction was22.97% compared to 3.28% in Control Group.
89.47% of subjects who consumed TTCompounded Asafoetida Powder showed ≥20%reduction in Post Prandial Glucose in just 96 days. The average reduction was25.83% compared to 0.30% in ControlGroup.
91.23% of subjects showed who consumed TTCompounded Asafoetida Powder ≥20% reduction in HbA1C in just 96 days. Theaverage reduction was 21.39% compared to 0.88% in Control Group.
**COHORT : DYSLIPIDEMIA : TRIGLYCERIDES**
The average reduction in Triglycerides was22.32% in Subjects who consumed TT Compounded Asafoetida Powder in just 96days, compared to 1.17% in the Control Group.
There was no statistically significantimprovement seen in other Triglycerides – Cholesterol, LDL, HDL, VLDL insubjects of both treatment and control groups.
**COHORT : GASTRITIS (AMLAPITTA SYMPTOMSSCORE)**
81.25% of subjects who consumed TTCompounded Asafoetida Powder showed a statistically significant reduction inGastritis as assessed by Amlapitta Symptoms Score in just 96 days, compared toControl Group, with a mean Total Score of 7.31 compared to 15.50 by ControlGroup
**COHORT : CONSTIPATION (CONSTIPATION SEVERITY SCALE)**
92.85% of subjects who consumed TTCompounded Asafoetida Powder showed a statistically significant reduction inConstipation 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 byControl Group
The mean reduction in Constipation SeverityScale used to assess Constipation was significantly higher compared to Control.
**COHORT : HYPERTENSION**
There was no statistically significantimprovement seen in Hypertension in subjects of both treatment and controlgroups.
**SAFETY AND TOLERABILITY**
A total of 6 adverse events were reported inthe clinical. 5 adverse events were reported in the treatment arm.
All adverse events were ruled not related tothe investigational product.
No serious adverse event was reported in thestudy.
TT Compounded Asafoetida Powder is deemedsafe for consumption.
**USE OF STANDARD THERAPY**
Subjects on a therapy regimen for DiabetesMellitus Type II (OHA, Insulin, AYUSH products or combination thereof continuedon the same throughout the treatment period along with the consumption of theInvestigational product.
No changes were made to the existing therapyregimen for Diabetes Mellitus Type II during the treatment period.
No treatment was allowed not consumed forcohort indications – Dyslipidemia, Gastritis, Constipation and Hypertension.
**CONCLUSION**
Consumption of TT Compounded AsafoetidaPowder with buttermilk significantly reduced Fasting Blood Glucose, HbA1C, PostPrandial Glucose in Subjects with Diabetic Mellitus Type II in 96 days.
Consumption of TT Compounded AsafoetidaPowder with buttermilk significantly reduced Triglycerides in Subjects withDyslipidemia in 96 days.
Consumption of TT Compounded AsafoetidaPowder with buttermilk significantly reduced Gastritis in 96 days.
Consumption of TT Compounded AsafoetidaPowder with buttermilk significantly reduced Constipation in 96 days.
**Hence, upon statistical analysis of theclinical study, TT Compounded Asafoetida Powder is recommended as a safe,clinically verified and validated product to help reduce Blood Sugar Levels inSubjects with Diabetes Mellitus Type II, to significantly reduce Triglycerides,Gastritis and Constipation**
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 80
- 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.
- 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.
- 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.
- Subjects who are on OHA or Insulin and or AYUSH remedies for the management of Diabetes Mellitus Type II 8.
- 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.
- Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
- Subjects with allergy, sensitivity or intolerance to the investigational product and or the formulation ingredients.
- 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.
- Subjects with complete cancer remission less than 3 years prior to the date of screening.
- 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.
- Subjects who are on anti-depressants, anti-psychotics.
- 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.
- Subjects who have participated in any clinical study within 3 months from the date of enrolment.
- Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
- Subjects, who in the opinion of the Investigator are not eligible for enrolment in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PPG 10% reduction 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 Dyslipidemia 10% reduction 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 Amlapitta Symptoms Scale 25% reduction 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 Constipation Severity Scale 25% reduction 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 Stage 1 Day 1to 48 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 Dyslipidemia 20% reduction 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 FBG 10% reduction 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 HbA1C 10% reduction 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 Hypertension : Improvement of 5 mmHg 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 Stage 2 Day 1to 96 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 FBG 125 mg/dL or 20% reduction 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 PPG 140 - 199 mg/dL or 20% reduction 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 Amlapitta Symptoms Scale Score of 8 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 Constipation Severity Scale Score of 5 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 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 HbA1C 6.4% A1C levels or 20% reduction 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 Measures
Name Time Method
Trial Locations
- Locations (1)
Raam Clinic
🇮🇳Chennai, TAMIL NADU, India
Raam Clinic🇮🇳Chennai, TAMIL NADU, IndiaDr VT SriraamPrincipal investigator9840909155md@auroushealthcare.com