| CTRI Number |
CTRI/2023/03/050816 [Registered on: 17/03/2023] Trial Registered Prospectively |
| Last Modified On: |
04/03/2023 |
| 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 Ayurveda panchakarma and rasayana therapy on gut microbiome in Diabetes patients |
|
Scientific Title of Study
|
Evaluating the potential mechanism and efficacy of shodhana-rasayana in comparison with Diabetic Specific Diet and Lifestyle modifications in the management of Madhumeha (Diabetes Mellitus Type 2)on fecal metagenomics - An in-silico and randomized comparative clinical study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mythri H S |
| Designation |
PhD scholar |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Department of Kayachikitsa, 6th floor, academic block, Block C
All India Institute of Ayurveda, Mathura road, Gautampuri, Sarita vihar, New Delhi
South
DELHI
110076
India |
| Phone |
9448727127 |
| Fax |
|
| Email |
drmythri.achar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raja Ram Mahto |
| Designation |
Assistant Professor and Consultant |
| Affiliation |
All India Institute of Ayurveda |
| Address |
room no 615, Department of Kayachikitsa, 6th floor, academic block, Block C
All India Institute of Ayurveda, Mathura road, Gautampuri, Sarita vihar, New Delhi
South
DELHI
110076
India |
| Phone |
8877033663 |
| Fax |
|
| Email |
mahtorajaram@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mythri H S |
| Designation |
PhD scholar |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Department of Kayachikitsa, 6th floor, academic block, Block C
All India Institute of Ayurveda, Mathura road, Gautampuri, Sarita vihar, New Delhi
South
DELHI
110076
India |
| Phone |
9448727127 |
| Fax |
|
| Email |
drmythri.achar@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda, Mathura road, Gautampuri, Sarita Vihar, New Delhi |
| CoE for Applied Development in Ayurvedic Prakriti and Genomics, funded by Ministry of AYUSH, TRISUTRA unit, Ayurgenomics lab, third floor, CSIR IGIB, Mathura road, New Delhi |
|
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Primary Sponsor
|
| Name |
All India Institute of Ayurveda, CoE TRISUTRA CSIR IGIB |
| Address |
All India Institute of Ayurveda, Mathura road, Gautampuri, Sarita Vihar, New Delhi
CoE, TRISUTRA, CSIR IGIB, South campus, Mathura road, Sukhdev vihar, New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| CoE TRISUTRA CSIR IGIB |
CoE, TRISUTRA, CSIR IGIB, South campus, Mathura road, Sukhdev vihar, New Delhi |
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mythri H S |
All India Institute of Ayurveda, Mathura road, Sarita Vihar, New Delhi |
OPD 07, Diabetes and Metabolic disorders unit, Ground floor, OPD Block, Hospital building
South
DELHI |
9448727127
drmythri.achar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIA Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Gokshuradi guggulu, Nishamalaki tablet, Sudarshana gudamar churna, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: ushna jala), Additional Information: oral medications like gokshuradi gugglu 500 mg 2tab tid, Nishamalaki 500mg 2 tab tid and sudarshana gudamar churna 6gm tid will be started after the completion of rasayana therapy | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Gokshuradi guggulu, Nishamalaki tablet, sudarshana gudmar churna, Reference: Bhaishajya ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: ushna jala), Additional Information: medications like Gokshuradi guggulu 500mg 2 tab tid, Nishamalaki tablet 500mg 2 tab tid, sudarshana gudmar churna 6gm tid will be given for 90 days along with Diabetic specific diet and lifestyle modification | | 3 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-करà¥à¤® | (Procedure Reference: Charaka Samhita Sutrasthana 15 chapter, Procedure details: Oil snehapana for 5 days followed by 2 days of vishrama kala and 8th day virechana, followed by 5 days of samsarjana krama and Shilajatu rasayana for 21 days)
(1) Medicine Name: Murchita tila taila, shuddha shilajatu rasayana, Reference: ch chi 1/3/54, Route: Oral, Dosage Form: Rasayoga, Dose: 12(g), Frequency: od, Duration: 21 Days | | 4 | Comparator Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Diabetes specific Diet and lifestyle modification, Pathya/Apathya:yes, Pathya:Diabetes specific Diet and lifestyle modification, Dwikala bhojana, compulsory everyday physical exercise , Apathya: |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with Diabetes Mellitus according to WHO criteria
Subjects diagnosed for Madhemha based on general diagnostic criteria according to document of Protocol for Prevention and Control of Diabetes through Ayurveda, MoA, Page no 37, 2016
Recently diagnosed (0-5 years) patients who are not on OHA (both overweight/obese and normal BMI – ICMR Asian criteria #)
Subjects of either gender aged more than 18 years, <60 yrs.
Willingness to consent to randomization |
|
| ExclusionCriteria |
| Details |
Emergency cases of diabetes or under immediate consideration for hospitalization and Type 1 DM or Insulin-dependent
Patient with inflammatory bowel disease Crohns disease or ulcerative colitis, chronic diarrhoea or malabsorption Hepatitis etc
Patient with a history of other complications with DM
Female patient who is pregnant, or breast feeding or is considering becoming pregnant during the study or for 6 months after the last dose of study medication
Patients having known hypersensitivity to any of the proposed trial drug
Currently under any other trial |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes in Blood sugar fasting and post prandial and HbA1C
Changes seen Deha bala agni bala chetas bala
Alterations seen in biomarkers such as, Apolipoprotein A1, Adiponectin, hs-CRP
Potential pathways and mechanism of Shilajatu along with ADR
|
Changes in Blood sugar fasting and post prandial and HbA1C -0,30, 60, 90th days
Changes seen Deha bala agni bala chetas bala- 0, 90th days
Alterations seen in biomarkers such as, Apolipoprotein A1, Adiponectin, hs-CRP-0th and 90th days
Potential pathways and mechanism of Shilajatu along with ADR
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes seen in Quality of Life in DM
Variations seen in LDL, HDL, TC, HDL/TG Ratio, VLDL and TG
Alterations in Gut microbiome analysis
|
0,30, 60, 90th days |
|
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Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
25/04/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Present study
is aiming to evaluate the efficacy of Virechana followed by Shilajatu rasayana
in patients of Diabetes Mellitus type 2, on various parameters like Blood sugar
fasting and post prandial and HbA1C, Apolipoprotein A1, Adiponectin, hs-CRP and
Ayurveda parameters like Deha bala, agni bala, chetas bala. Study is also
aiming to see the gut microbiome alterations post Shodhana rasayana therapy in patients of Diabetes Mellitus
type 2, which is a first ever attempt to study the same. Study also includes
in-silico pathway analysis and ADR prediction of of present Rasayana drug |