| CTRI Number |
CTRI/2019/02/017755 [Registered on: 21/02/2019] Trial Registered Prospectively |
| Last Modified On: |
13/02/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
|
A RANDAOMIZED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF PATHYA, SHODHANA, SHAMANA AND RASAYANA CHIKITSA IN THE MANAGEMENT OF MADHUMEHA W.S.R TO TYPE II DIABETES MELLITUS. |
|
Scientific Title of Study
|
A CLINICAL STUDY TO EVALUATE THE EFFICACY OF PATHYA, SHODHANA, SHAMANA AND RASAYANA CHIKITSA IN THE MANAGEMENT OF MADHUMEHA W.S.R TO TYPE II DIABETES MELLITUS. |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vijayalakshmi |
| Designation |
Assistant Professor |
| Affiliation |
SKAMCH & RC |
| Address |
Dept of Kayachikitsa, Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research center
Vijaynagar Bangalore
Bangalore
KARNATAKA
560104
India |
| Phone |
9964815059 |
| Fax |
|
| Email |
drviju.prati.09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abdul Khader |
| Designation |
Professor |
| Affiliation |
Rajiv gandhi university of health sciences |
| Address |
Dept of Kayachikitsa, Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research center
Vijaynagar Bangalore
Bangalore
KARNATAKA
560104
India |
| Phone |
9845199790 |
| Fax |
|
| Email |
abukaya2003@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijayalakshmi |
| Designation |
Assistant Professor |
| Affiliation |
SKAMC H RC |
| Address |
Dept of Kayachikitsa, Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research center
Vijaynagar Bangalore
Bangalore
KARNATAKA
560104
India |
| Phone |
9964815059 |
| Fax |
|
| Email |
drviju.prati.09@gmail.com |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
SKAMC H RC |
| Address |
Dept of Kayachikitsa,No.10 pipelineroad vijayanagar 2nd stage RPC layout Bangalore-104 |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
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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 Vijayalakshmi S |
SKAMC H R C |
No 10 pipeline road RPC Layout
Vijaynagar Bangalore - 104
Bangalore
KARNATAKA |
9964815059
drviju.prati.09@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SKAMCHRC |
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, |
|
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
RANDOMISED, COMPARATIVE CLINICAL STUDY |
IN MADHUMEHA WSR TO TYPE2 DM. 200 PATIENTS RANDOMLY ASSIGNED INTO 4 EQUAL GROUPS AS FOLLOWS
GROUP A: ADMINISTRATIONOF YAVA VATYA MANDA FOR BREAKFAST FOR 3 MONTHS.
GROUP B: VIRECHANA FOLLOWED ADMINISTRATION OF YAVA VATYA MANDA FOR BREAKFAST FOR 3 MONTHS.
GROUP C : VIRECHANA FOLLOWED ADMINISTRATION OF YAVA VATYA MANDA FOR BREAKFAST FOR 3 MONTHS AND PANCHATIKTA KASHAYA BHAVITA TRIVANGA BHASMA 125mg WITH USHNA JALA TWICE DAILY, AFTER FOOD.
GROUP D: VIRECHANA FOLLOWED ADMINISTRATION OF YAVA VATYA MANDA FOR BREAKFAST FOR 3 MONTHS AND PANCHATIKTA KASHAYA BHAVITA TRIVANGA BHASMA 125mg WITH USHNA JALA TWICE DAILY, AFTER FOOD ALONG WITH GUDUCHI SATWA 1gm WITH USHNA JALA, ONCE DAILY BEFORE BREAKFAST.
TOTAL DURATION OF THE INTERVENTION 90 DAYS |
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Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients presenting with the lakshanas of Madhumeha.
2. Patients presenting the signs and symptoms of Type 2 Diabetes mellitus.
3. Patients fit for Virechana Karma.
|
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| ExclusionCriteria |
| Details |
1.Patient with other systemic disorders which interferes with the course of treatment.
2.Pregnant and Lactating women.
3.Patients with Juvenile Diabetes, Type 1 Diabetes mellitus.
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Method of Generating Random Sequence
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Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
|
Centralized |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| TO ASSESS THE ROLE AND RELEVANCE OF DIET AND TREATMENT (SHODHANA, SHAMANA AND RASAYANA) IN THE MANAGEMENT OF MADHUMEHA w.s.r TO TYPE 2 DIABETES MELLITUS. |
90 days |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| THE FINAL BENEFICIARIES WILL BE PATIENTS, RESEARCHERS AND AYURVEDIC PHYSICIANS |
90 days |
|
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Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
02/09/2019 |
| 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="4"
Months="1"
Days="1" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
NIL |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
|
MADHUMEHA IS EXPLAINED AS ONE AMONG THE VATAJA PRAMEHAS AND CHARACTERIZED BY MADHURYATA OF BOTH MUTRA AND SHARIRA. THE DISEASE MADHUMEHA EXPLAINED IN AYURVEDA IS SIMILAR TO DIABETES MELLITUS (DM). IN MODERNIZED ERA, THE SEDENTARY LIFE STYLE HAS ADVERSELY AFFECTED THE HOMEOSTASIS OF HUMAN BODY GIVING RISE TO VARIOUS LIFE STYLE DISEASES. DIABETES MELLITUS REFERS TO GROUP OF COMMON METABOLIC DISORDERS THAT SHARE THE PHENOTYPE OF HYPERGLYCEMIA. GLOBALLY, AS OF 2010, AN ESTIMATED 285 MILLION HAD DIABETES, WITH TYPE 2 MAKING UP ABOUT 90% OF CASES. IN 2013, ACCORDING TO INTERNATIONAL DIABETES FEDERATION, AN ESTIMATED 381MILLION PEOPLE HAD DIABETES AND ITS PREVALENCE IS INCREASING RAPIDLY, AND BY 2030, THIS NUMBER IS ESTIMATED TO BE DOUBLE. IT IS THE DISORDER, WHEN UNCONTROLLED MAY LEAD TO CLUSTER OF COMPLICATIONS LIKE RENAL FAILURE, NONTRAUMATIC LOWER EXTREMITY AMPUTATIONS AND ADULT BLINDNESS THEREBY AFFECT THE SOCIO - ECONOMIC STATUS. AYURVEDA CLASSICS PROVIDE REFERENCES ON PATHYA AHARA VIHARA, SHODHANA KARMA AND VARIOUS HERBAL AND HERBO-MINERAL DRUGS WHICH CAN BE SAFELY USED IN MANAGEMENT OF DIABETES MELLITUS. MADHUMEHA IS ANUSHANGI VYADI AND IS SAID TO BE KRUCHRA SADHYA GIVING SCOPE FOR THE UTILIZATION OF RASAYANA DRAVYAS FOR THE TREATMENT. ACHARYA SHARANGADHARA GIVES GUDUCHI AS AN EXAMPLE WHICH HAS RASAYANA PROPERTY. FOR THE PURPOSE OF KLEDA NIRHARANARTHA SHODHANA IS ADVISED AS THE LINE OF TREATMENT FOR WHICH VIRECHANA KARMA CAN BE ADOPTED. THIS STUDY IS DOUBLE ARM OPEN LABELLED COMPARATIVE CLINICAL STUDY COMPARING THE EFFICACY OF PATHYA, SHODHANA KARMA, SHAMANA CHIKITSA AND RASAYANA CHIKITSA IN THE MANAGEMENT OF MADHUMEHA. WSR TO TYPE 2 DIABETES MELLITUS 90 DAYS FOR 4 GROUPS WITH 50 PATIENTS IN EACH GROUP WHICH INCULDES THE CLASSICAL SIGN & SYMPTOMS OF MADHUMEHA. THIS STUDY WILL BE CONDUCTED IN SRI KALABYRAVESHWARA SWAMY AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER, BENGALURU, KARNATAKA. |