| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R730||Abnormal glucose. Ayurveda Condition: PRAMEHA-PURVARUPAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (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: - | | 2 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-करà¥à¤® | (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 |
|
|
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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. |
|
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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. |
|
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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. |