A Randomized controlled Clinical Study to evaluate add on effect of Gomutra Triphala Vati with oral Hypoglycemic agent in Prameha(Type II Diabetes Mellitus)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- To evaluate the add on effect of Gomutra Triphala Vati 500mg twice a day with oral hypoglycemic agent
Study Overview
Brief Summary
Prameha is known since vedic period. Prameha can be correlated with Diabetes because of having similarities of the disease .it is not single disease it is group of many many diseases. It is global health problem and receiving much attention now a days. Ancient Ayurveda physicians like Charak, Sushrut, Vagbhat were explained about this disease in detail and Brihattraee included Prameha in Ashtaumahagadawhich denotes its importance during those days.Prevalence of (Diabetes Mellitus )The prevalence of type 2 diabetes is 2.4% in Rural population and 11.6% in Urban population. According to data presented by WHO in year 2000, 171 million people were suffering from diabetes, out of them 31.7 million were belonging to India. In 2030 the total number of people with diabetes is projected to rise from 171 million to 366 million. According to International Diabetes Federation Estimated figure of Diabetics in India by year 2030 is 31.7 to 79.4 million which will be 1/5th of the total diabetic population at that time.
Aacharya Charaka has described following Hetus (causative factors ) for Prameha like Aasya Sukha (sedentary lifestyle) ,Swapna Sukha (excessive sleep),Dadhini (excessive intake of curd), Gramya-Audak-Anupa-Rasa (increased intake of meat of pet,aquatic animals which are living in excessive humid condition), Annapan (more consumption of new grains),Gud Vaikrutam (increased consumption
of all jaggery product).On the basis of pathophysiology above hetus causes vitiation of Tridosha specially Kaph with increased in Kleda which leads to Dhatwagnimandya.The indication of disease is described as a Prabhuta Avilmutrata which means frequent urine with turbidity. Prameha is a syndrome which include all those distant conditions which are characterized by increased quantity of urine associated with or without the increased frequency of micturation polyurea and turbidity of the urine are two essential presenting factors of disease.Prameha Dushyas are Meda, Mansa, Kleda, Shukra, Shonita, Vasa, Majja, Lasika, Rasa & Oja associated with three morbid Doshaj manifests different subtypes of Prameha which causes vitiation of all above Dushyas and Oja. All these vitiated Doshaj Kleda and Dhatus get accumulated in Basti to complete the Samprapti of Prameha.
Now a day due to the Sedentary life style, Stress and irregular dietary habits the ratio of Prameha is increasing day by day in society and availability of patients is more.Many Ayurvedic practitioners are regularly using Triphala successfully for the treatment of Prameha but there is no substantial research done till now on usage of Gomutra Triphala Vati for the treatment of Prameha hence, this subject selected for the research work.Since Gomutra Triphala Vati possesses all properties of potent medicine useful for Prameha Chikitsa.To evaluate an adjuvant effect of Gomutra triphala Vati in Prameha with Oral Hypoglycemic Agent this study designed. All contains of trial drug has properties like Kledaghna, Medodushutighna, Rasayana, Kaphghna, Medodhatwagni Vardhan properties. All the ingredients present Gomutra Triphala Vati are easily available.
Therefore, this formulation was choosen for present study. reference of this preparation is taken from Sharangdhar samhita and Bhavprakash Nighantu.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Open Label
Eligibility Criteria
- Ages
- 35.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Age group between 35 to 60 years.
- •Known case of Type-2 DM, Non insulin dependent diabetes mellitus.
- •Patient having HbA1C between 6.5 –
- •Patient with fasting blood sugar up to 250 mg/dl and post prandial blood sugar up to 350 mg/dl
- •Patient taking Oral hypoglycemic drug since minimum 6 months.
Exclusion Criteria
- •Juvenile Diabetes and Insulin Dependent Diabetes Mellitus (IDDM).
- •Post covid diabetic patients.
- •Patients with Renal Disorders like Chronic kidney disease and Acute kidney diseases.
- •Patients with acute complications Hyperglycemic & hypoglycemic coma, Ketoacidosis and related complication and Infections like gangrene.
- •Pregnant & lactating women.
Outcomes
Primary Outcomes
To evaluate the add on effect of Gomutra Triphala Vati 500mg twice a day with oral hypoglycemic agent
Time Frame: study time 3 months | follow up 30th, 60th, 90th days
in Prameha (Type II DM) for 3 months.
Time Frame: study time 3 months | follow up 30th, 60th, 90th days
Secondary Outcomes
- To observe adverse effects if any.(study time 3 months)