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Clinical Trials/CTRI/2022/02/040617
CTRI/2022/02/040617CompletedPhase 2/3

A Randomised Controlled Clinical Trial To Evaluate The Effect Of Sunthi Dhanyak Sadhita Jala And Ushnodaka As Compared To Normal Water Along With Comprehensive Ayurvedic Lifestyle Intervention On Weight Among Individuals With Prameha Purvaroopa (Prediabetes)

All India Institute of Ayurveda2 sites in 1 country114 target enrollmentStarted: October 20, 2022Last updated:

Trial Snapshot

Phase
Phase 2/3
Status
Completed
Enrollment
114
Locations
2
Primary Endpoint
Change in weight of the patients

Study Overview

Brief Summary

HYPOTHESIS

ALTERNATIVE HYPOTHESIS (H1)

Among individuals with Prameha poorvarupa (prediabetes) from study area who drink Sunthi-Dhanyak sadhita jala/ ushnodakaalong with comprehensive ayurvedic lifestyle intervention for at least 3 months results in average reduction of 2.5 to 5 kg of weight as compared to those who drink normal water along with comprehensive ayurvedic lifestyle intervention.

NULL HYPOTHESIS (H0)-

None of the three (Sunthi-Dhanyaka sadhita jala /Ushnodaka/Normal water) along with comprehensive ayurvedic lifestyle intervention are effective in Prameha purvaroopa (prediabetes).

INTRODUCTION

Increasing prevalence of type 2 diabetes mellitus (DM) has become alarming, burdening health care systems throughout the world. Pre-diabetes is a condition where a person has impaired glucose metabolism, but hasn’t yet developed diabetes. Prediabetes, also called as intermediate hyperglycaemia. A person with pre-diabetes is at greater risk of going on to develop type 2 diabetes.  Prediabetes is an intermediate step before manifestation of full-blown DM. Effective intervention at this step would help stop/slow progression to DM.

Estimated prevalence of Prediabetes in India 14%. 1 in 6 Indian is suffering from prediabetes (1).

A weight loss of 11% can reverse pre-diabetes in Obese people, a global study shows

(Intervention -8-week Cambridge weight plan formula diet of 800 kcal /day best mix of diet and exercise). There is already good clinical evidence for maintaining a 5% weight loss in non-diabetic people for over 3 years (2). Studies have reported a higher likelihood of progression of prediabetes to type 2 diabetes mellitus (3). Early intervention at Prediabetes stage would help to slow/stop progression towards diabetes.

Human body consists of 80% of water. Now a days everyone is aware of diet but for paan most of us are dependent on mere RO (Reverse osmosis) or DM

(Demineralised) or Kangen (too costly) water and not focusing more than that. In Ayurveda classics Anna is always associated with Paan, adhyayawere named as“Annapaanâ€in brihat samhitasAnna is important for prana dharan in dhatus whereas paan is important for prana vahan in dhatus (that’s whyUshapaanis indicated as a part of dincharayastarting to cleanse our system*). Anna*is important for *Anuvartana (nutrional status) whereas paanis medium for stabilizing the Samvayata(body framework). We take Anna(diet) less in comparison to paan throughout the day (2-3L). Paanis the medium to distribute adequately poshakansha anna rasa at cellular level via permeability or better absorption or assimilation or opening and smoothening the body Strotas (channels); act as pH and glucose regulators in the body. Water act as a medicine if taken in indigestion, gives strength if taken after digestion of food, good while having meal and bad if taken immediately after meals (4). Decoction of water is doshagna, pachana and laghu (5). Analysing the importance of water and paan,*the title for research is chosen.

People who are at risk to develop prediabetes should be screened or detected earlier and needs to be treated via breaking the chain of initial pathogenesis before worsening the condition of developing diabetes type 2. So, it is the approach to treat them in simplest way by Paanand comprehensive Ayurveda intervention.

Taking into account its global prevalence prediabetes control has become the need of hour.

Weight reduction in the prediabetes (with simplest method like Paan along with comprehensive ayurvedic intervention) if could reverse the pathogenesis of Diabetes, which is a silent killer and irreversible condition; burdening health care systems throughout the world.

If it could either delay or slow down its progression by reversing the pathogenesis and stop its conversion into type 2 diabetes then complications associated with this condition like heart disease, stroke, nerve damage, and others could also be avoided. Thus, would be helpful in improving health status of the society.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Open Label

Eligibility Criteria

Ages
20.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Middle class family having RO purifier -Overweight and obese (BMI 23.0-29.9 kg/m2) -Any Sign/ symptoms of Prameha Purvaroopa as per classics along with HbA1C (5.7 to 6.4%) -Willing to participate and able to comply the study procedures and willing to give written informed consent.

Exclusion Criteria

  • Pregnancy -Lactating mothers -Gestational diabetes -Diabetic case (patients on oral hypoglycaemic drugs or insulin) -Tuberculosis -Chronic kidney disease -Chronic Heart diseases -Chronic liver disease -Chronic obstructive pulmonary disease -Malignancies -Undergone any surgery within 2 months -Not willing to participate.
  • Any other criteria or major illnesses that investigator find inappropriate for the study will not be taken.

Outcomes

Primary Outcomes

Change in weight of the patients

Time Frame: at baseline and every 15 days of follow up till 3 months of intervention

Secondary Outcomes

  • Changes in HbA1c, Lipid profile, TFT and Changes in quality of life via SF-36 questionnaire(investigations and QOL at baseline and after 3 months on trial completion.)

Investigators

Sponsor Class
Government medical college

Study Sites (2)

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