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CTRI Number  CTRI/2024/05/067448 [Registered on: 15/05/2024] Trial Registered Prospectively
Last Modified On: 09/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Virechana (a Panchakarma treatment) followed by oral administration of Nisha Amalaki Yoga in prediabetes 
Scientific Title of Study   An Open Labelled Randomised Comparative Clinical study to Evaluate the efficacy of Virechana (Medicated Purgation) and Nisha Amalaki Yoga in the management of Prediabetes  
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 Anany Trivedi 
Designation  PG Scholar 
Affiliation  Parul Institute of Ayurved 
Address  OPD No 116 Department of Kayachikitsa Parul Ayurved Hospital Parul University AP Limda Tal Waghodiya Vadodara GUJARAT

Vadodara
GUJARAT
391760
India 
Phone  9904101515  
Fax    
Email  ananytrivedi5@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shailesh V Deshpande 
Designation  Professor & HOD 
Affiliation  Parul Institute of Ayurved 
Address  OPD No 116 Department of Kayachikitsa Parul Ayurved Hospital Parul University AP-Limda Tal Waghodiya Vadodara, GUJARAT

Vadodara
GUJARAT
391760
India 
Phone  9763104451  
Fax    
Email  dr.shaileshd@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Divya B 
Designation  Associate Professor 
Affiliation  Parul Institute of Ayurved and Research 
Address  OPD No 07 Department of Panchkarma,Khemdas Ayurved Hospital, Ishwarpura, Vadodara, GUJARAT

Vadodara
GUJARAT
391760
India 
Phone  9844810958  
Fax    
Email  dr.divyadeva3@gmail.com  
 
Source of Monetary or Material Support  
Parul Institute of Ayurved, Parul University, AP-Limda, TAL- Waghodia, Vadodara ,Gujarat, India - 391760 
 
Primary Sponsor  
Name  Parul Institute of Ayurved  
Address  Faculty of Ayurved, Parul University,AP- Limda, TAL-Waghodia, DIST-Vadodara, Gujarat, India-391760  
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 Anany Trivedi  Parul Ayurved Hospital  OPD No 116 Department of Kayachikitsa, Parul Ayurved Hospital, Parul University, AP-Limda, Tal.-Waghodia,Vadodara
Vadodara
GUJARAT 
9904101515

ananytrivedi5@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Parul Institute of Ayurved - Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:R730||Abnormal glucose. Ayurveda Condition: PRAMEHA-PURVARUPAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Nisha Amalaki, Reference: Astanga Hrdayam, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: -
2Intervention ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: Charak Samhita, Procedure details: Virechana Karma followed by Nisha Amalaki Yoga for 90 days)
(1) Medicine Name: Trivrut Lehyam, Reference: Astanga Hrdayam, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 30(g), Frequency: od, Duration: 1 Days
(2) Medicine Name: Nisha Amalaki, Reference: Astanga Hrdayam, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1(g), Frequency: bd, Duration: 90 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of pre-diabetes diagnosis according to American Diabetes Association (HbA1C - 5.7 to 6.4 %).
Patients eligible for Virechana.
Patients willing to sign informed consent and able to participate in the study procedure. 
 
ExclusionCriteria 
Details  Known cases of Diabetes Mellitus, Insulin Dependent Diabetes, Juvenile Diabetes Mellitus And Gestational Diabetes.
Known cases of Major Systemic Diseases like IHD, Malignancies, Uncontrolled Hypertension.
Patients on prolonged medication (more than 6weeks) with Corticosteroids or any other Drug that may have an influence on the outcome of the study.
Pregnant and lactating women.
Patients with active infective diseases like Tuberculosis, Hepatitis B.
Immunocompromised patients. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the effect of Virechana followed by Nisha Amalaki Yoga & Nisha Amalaki Yoga alone in patients on the basis of HbA1C,Lipid Profile,Fasting and post prandial blood sugar level in patients of Prediabetes.  HbA1C-On Screening Visit and 90th Day.
Lipid Profile-On Screening Visit,After Virechana Karma and 90th Day.
FBS-On Screening Visit,After Virechana Karma,30th Day,60th Day and 90th Day.
PP2BS-On Screening Visit,After Virechana Karma,30th Day,60th Day and 90th Day.
 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the effect of Virechana followed by Nisha Amalaki Yoga and Nisha Amalaki Yoga alone in patients on the basis of BMI,Body composition parameters and other subjective parameters in patients of Prediabetes.  On Screening Visit,After Virechana Karma,15th Day,30th Day,45th Day,60th Day,75th Day and 90th Day. 
To study the safety of Virechana and Nisha Amalaki Yoga in patients of Prediabetes.  On Screening Visit,After Virechana Karma,15th Day,30th Day,45th Day,60th Day,75th Day and 90th Day. 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/06/2024 
Date of Study Completion (India) 30/09/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  
In modern science, there isn’t a specific treatment for prediabetes, instead, healthcare professionals recommend lifestyle modifications such as dietary changes and increased physical activity to manage the condition. Many individuals diagnosed with prediabetes, despite being aware of the risks, struggle to implement necessary lifestyle modifications. The challenge often stems from entrenched habits, societal influences, and a lack of perceived urgency. Inertia sets in as people find it difficult to break free from familiar patterns. Procrastination and misconceptions about the severity of prediabetes can lead to complacency.Limited research exists on prediabetes in Ayurveda, hindering comprehensive understanding and treatment approaches. If we go through the literature of Prameha, all acharyas described Prameha Poorvarupa in details. Prameha is Bahudoshaja Vyadhi and in early course of the disease Shodhana must be the choice of treatment as at this stage predominance of Kapha and
Pitta Dosha found in patients. Virechana is the best Shodhana therapy for the elimination of Dosha through the lower route of the body. By the elimination of Kapha and Pitta, obstructions are removed (Avarana), which are caused by Vata. At the same time, the elimination of Kapha also alleviates the vitiated Kapha Vargiya Dushyas. In this way, the Virechana therapy reduces the vitiation of Dosha and the Dushya. When the Shamana drug will be given to the patients whose vitiated Doshas were already eliminated by the Virechana therapy, ultimately it may provide better result to the patients. Currently, there is a lack of available data on the implementation of Virechana Karma in the treatment of conditions like prediabetes followed by Shaman Aushadha. The scarcity of research or documented cases highlights the need for further exploration and investigation into the effectiveness and appropriateness of employing Virechana in managing prediabetes hence this study will be undertaken.
Nisha Amalaki Yoga possesses the Tridoshahara characteristic with a specific emphasis on its Kaphahara property.It acts on vitiated Kapha ,Meda and Kleda, demonstrating the capability to enhance the tone of the Saptadhatus while reducing Dhatushaithilya.Through its Deepan and Pachan attributes, Nisha Amalaki Yoga influences Jatharagni and Dhatwagni, thereby decreasing the presence of Ama and Kleda in the body.It enhances Dhatwagni, contributing to
the amelioration of disturbed metabolism. Nisha Amalaki Yoga exhibits Deepan, Pachan and Anuloman properties, which collectively work on Strotodushti and glucose metabolism. Its Ruksha Guna facilitates Kleda Shoshana, and may be beneficial in the Sampraprti Vighatan of Prameha. Hence, evaluation of the medicine in pre-diabetes may be useful and needs to be explored. In view of Ayurvedic principles of management of Prameha after Shodhana treatment is completed, Shodhana plays important role. Hence in current study, it is praposed to evaluate effect of both Shodhana and Shamana in comparision with Shamana alone in the management in prediabetes.
 
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