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CTRI Number  CTRI/2023/10/058920 [Registered on: 19/10/2023] Trial Registered Prospectively
Last Modified On: 28/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To study add on effect of Gomutra Triphala Vati with oral Hypoglycemic agent in Prameha(Type II Diabetes Mellitus) 
Scientific Title of Study   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 Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ankita Balaso Bongane 
Designation  PG Scholar 
Affiliation  PDEAs Of Ayurved And Research Centre Nigdi PuneCollege 
Address  PDEAs College Of Ayurved And Research Centre Kayachikitsa Department Third Floor Nigdi Pune Maharashtra 411044 India

Pune
MAHARASHTRA
411044
India 
Phone  9834232144  
Fax  0  
Email  ankitabongane18@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Medha M Joshi 
Designation  Professor & HOD 
Affiliation  PDEAs College Of Ayurved And Research Centre Kayachikitsa Department Third Floor Nigdi Pune 
Address  PDEAs College Of Ayurved And Research Centre Kayachikitsa Department Third Floor Nigdi Pune Maharashtra 411044 India

Pune
MAHARASHTRA
411044
India 
Phone  8104332338  
Fax  0  
Email  medhamaheshjoshi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Medha M Joshi 
Designation  Professor & HOD 
Affiliation  PDEAs College Of Ayurved And Research Centre Kayachikitsa Department Third Floor Nigdi Pune 
Address  PDEAs College Of Ayurved And Research Centre Kayachikitsa Department Third Floor Nigdi Pune Maharashtra 411044 India


MAHARASHTRA
411044
India 
Phone  8104332338  
Fax  0  
Email  medhamaheshjoshi@gmail.com  
 
Source of Monetary or Material Support  
PDEAs College of Ayurved and Research center nigdi pune 
 
Primary Sponsor  
Name  PDEAs College Of Ayurved And Research Centre Nigdi pune 
Address  PDEAs College Of Ayurved And Research Centre Kayachikitsa Department Third Floor Nigdi Pune Maharashtra 411044 India 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ankita Bongane  Ayurved Rugnalaya And Sterling Multispeciality hospital Pune  Ayurved Rugnalaya and Sterling Multispeciality hospital sector no 27 kayachikitsa department opd no 117 nigdi pradhikaran Pune 411044 Maharashtra
Pune
MAHARASHTRA 
9834232144
0
ankitabongane18@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  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: PRAMEHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Gomutra triphala, Reference: Bhavprakash ,Sharangadhar smhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Koshnajala), Additional Information: Apankal
2Comparator Arm (Non Ayurveda)-MetforminTab metformin 500mg BD Before meal
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Age group between 35 to 60 years.
2. Known case of Type-2 DM, Non insulin dependent diabetes mellitus.
3. Patient having HbA1C between 6.5 – 10.
4. Patient with fasting blood sugar up to 250 mg/dl and post prandial blood sugar
up to 350 mg/dl
5. Patient taking Oral hypoglycemic drug since minimum 6 months. 
 
ExclusionCriteria 
Details  1. Juvenile Diabetes and Insulin Dependent Diabetes Mellitus (IDDM).
2. Post covid diabetic patients.
3. Patients with Renal Disorders like Chronic kidney disease and Acute kidney
diseases.
4. Patients with acute complications Hyperglycemic & hypoglycemic coma,
Ketoacidosis and related complication and Infections like gangrene.
5. Patients with chronic diabetic complications Nephropathy, Neuropathy and
Retinopathy.
6. Pregnant & lactating women. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the add on effect of Gomutra Triphala Vati 500mg twice a day with oral hypoglycemic agent
in Prameha (Type II DM) for 3 months. 
study time 3 months
follow up 30th, 60th, 90th days
 
 
Secondary Outcome  
Outcome  TimePoints 
To observe adverse effects if any.  study time 3 months
follow up 30th, 60th, 90th days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   28/10/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
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.
 
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