CTRI Number |
CTRI/2020/02/023430 [Registered on: 19/02/2020] Trial Registered Prospectively |
Last Modified On: |
09/02/2020 |
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 Haridra Churna (Haldi) in Reducing Blood Sugar in Madhumeha (Diabetes Mellitus) |
Scientific Title of Study
|
A Comparative study to evaluate the Hypoglycaemic Effect of Haridra Churna and Chandraprabha Vati in Madhumeha (Type-2 Diabetes Mellitus) |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Prof DR N R Singh |
Designation |
Professor (P.G. Department of Kayachikitsa) |
Affiliation |
Department of Kayachikitsa, Ch. Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, New Delhi-73 |
Address |
Department of Kayachikitsa,Ch. Brahm Prakash Ayurved Charak Sansthan,Khera Dabar, New Delhi-73
South West DELHI 110073 India |
Phone |
9560659728 |
Fax |
|
Email |
naimishraj@yahoo.com |
|
Details of Contact Person Scientific Query
|
Name |
Prof Dr N R Singh |
Designation |
Professor (P.G. Department of Kayachikitsa) |
Affiliation |
Department of Kayachikitsa, Ch. Brahm Prakash Ayurved Charak Sansthan |
Address |
Department of Kayachikitsa, Ch. Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, New Delhi-73
South West DELHI 110073 India |
Phone |
9560659728 |
Fax |
|
Email |
naimishraj@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Dr Alisha |
Designation |
MD Scholar (Department of Kayachikitsa) |
Affiliation |
Department of Kayachikitsa, Ch. Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, New Delhi-73 |
Address |
Department of Kayachikitsa, Ch. Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, New Delhi-73
South West DELHI 110073 India |
Phone |
8447536145 |
Fax |
|
Email |
alishadhaniya@gmail.com |
|
Source of Monetary or Material Support
|
Department of Kayachikitsa Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar New Delhi 110073 |
|
Primary Sponsor
|
Name |
Department of Kayachikitsa Ch Brahm Prakash Ayurved Charak Sansthan |
Address |
Department of Kayachikitsa, Ch. Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, New Delhi-73
|
Type of Sponsor |
Other [ [Autonomous Ayurvedic Medical college and Hospital under Govt of NCT of Delhi] ] |
|
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 |
Prof Dr N R Singh |
Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar New Delhi |
Room no 146,Department of Kayachikitsa, Ch. Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, New Delhi-73
South West DELHI |
9560659728
naimishraj@yahoo.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
IEC-CBPACS |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Chandraprabha Vati |
40 patients will be randomly selected for this group and they will be treated with Chandraprabha Vati19– in dosage of 500 mg twice in a day for 21 days with Pippali Churna 500mg half an hour before meal for 21 days |
Intervention |
Haridra Churna with Pippali Churna |
40 patients will be randomly selected for this group and they will be treated with Haridra Churna in dosage of 3gm twice in a day for 21 days with ‘Pippali Churna’ 500mg half an hour before meal.for 21 days |
|
Inclusion Criteria
|
Age From |
40.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1. Patients with age between 40-60yrs.
2. Sex: Both male and female
3. Patients fulfilling the diagnostic criteria for Diabetes Mellitus framed by the AMERICAN DIABETES ASSOCIATION.
4. FBS-126-200mg/dl PPBS-150-350mg/dl
5. HbA1c 7% and more
6. Patients taking any type of oral anti-diabetic treatment from 1. Biguanides and 2. Sulfonylurea
1. Patients with age between 40-60yrs.
2. Sex: Both male and female
3. Patients fulfilling the diagnostic criteria for Diabetes Mellitus framed by the AMERICAN DIABETES ASSOCIATION.
4. FBS-126-200mg/dl PPBS-150-350mg/dl
5. HbA1c 7% and more
6. Patients taking any type of oral anti-diabetic treatment from 1. Biguanides and 2. Sulfonylurea
|
|
ExclusionCriteria |
Details |
1. Patients below the age of 40 years and more than the age of 60 years
2. Fasting Blood Sugar Level <126 mg/dl and >200 mg/dl
• Post Prandial Blood Sugar Level <180 mg/dl and >350 mg/dl
3. HbA1c <7%.
4. Patients depending on the insulin for blood glucose control.
5. Patients with diabetic complications.
6. Patients suffering from Secondary Diabetes.
7. Gestational diabetes.
8. Pregnant ladies and lactating mothers.
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Reduction in Prabhootmutrata (excessive urine)
Reduction in Avilamutrata (Turbid urine)
Reduction in Mutra Madhuryata (Sweetness in urine)
|
Prabhootmutrata (excessive urine)
Avilamutrata (Turbid urine)
Mutra Madhuryata (Sweetness in urin)
Swapnasheela (sleep)
Atikshudha
(Excessive hunger)
Atisweda (Excessive sweating)
Daurbalya (Weakness)
Atitrushna (Excessive thirst)
on Day 0 Day1 Day 7 Day 14 Day 21 |
|
Secondary Outcome
|
Outcome |
TimePoints |
Reduction in swapnasheela (sleep)
Reduction in atikshudha
(Excessive hunger)
Reduction in atisweda (Excessive sweating)
Reduction in daurbalya (Weakness)
Reduction in atitrushna (Excessive thirst)
|
Swapnasheela (sleep)
Atikshudha (Excessive hunger)
Atisweda (Excessive sweating)
Daurbalya (Weakness)
Atitrushna (Excessive thirst)
on Day 0 Day 1 Day7 Day 14 Day221 |
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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
|
Phase 4 |
Date of First Enrollment (India)
|
27/02/2020 |
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 Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
none |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Madhumeha is
a clinical entity described in Ayurveda as one of the types of Vataja Prameha.
Regarding this disease Ayurvedic scholars have mentioned that Madhumeha
is caused by aggravation of Vata, the patient passes excess urine
which is sweet, astringent in taste, slightly turbid and pale in
color. Describing the Prameha, the cardinal feature of Prameha has
been mentioned as Avile Prabhuta Mutrata. Madhumeha is
caused by Dhatukshaya manifests as thin and asthenic
individual due to loss of Oja or imbalance in Oja. In Margavaranjanya
Madhumeha the vitiated Kapha and Meda obstruct
the passage of Vata. The obstructed Vata is vitiated again and
carries Ojas to Basti thus manifests Madhumeha.
Madhumeha can be correlated with a similar disease described in modern
medical sciences as Diabetes mellitus, which is a syndrome with disordered
metabolism and inappropriate hyperglycemia, due to either a deficiency of
insulin secretion or to a combination of insulin resistance and inadequate
insulin secretion to compensate. Diagnostic emphasis then shifted to the
glucose levels themselves and in addition to diabetes a milder level of
hyperglycemia denoted impair glucose tolerance has been defined by the W.H.O.
Aim is to compare the Hypoglycaemic effect of Haridra
Churna and Chandraprabha Vati in Madhumeha (Type 2
Diabetes Mellitus) along with Pippali Churna as
adjuvant. Objectives are to evaluate the effectiveness of Haridra
Churna along with Pippali Churna as adjuvant in Madhumeha (Type
2 Diabetes Mellitus), To evaluate the effectiveness of Chandraprabha
Vati along with Pippali Churna as
adjuvant in Madhumeha (Type 2 Diabetes
Mellitus), To compare the hypoglycemic effect of Haridra
Churna and Chandraprabha Vati in Madhumeha (Type 2
Diabetes Mellitus) along with Pippali Churna as adjuvant.
Study design is Single centred, Open label, Comparative
Study, Randomized control study, Efficacy study, with one of active control
without any crossover. Study area is OPD & IPD of Ch. Brahm
Prakash Ayurveda Charak Sansthan, Khera Dabar, New Delhi. Study population
is Diagnosed patients of Type-2 Diabetes Mellitus will be selected for
this purpose on the basis of inclusion criteria. Detail of drug
administration is Haridra Churna– In dosage of 3gm twice in a
day for 21 days with ‘Pippali Churna’ 500mg half an hour before meal
in Group A (Trial group). Chandraprabha Vati– in dosage of 500
mg twice in a day for 21 days with ‘Pippali Churna’ 500mg half an hour
before meal in Group B (Comparator group).
Inclusion criteria involves 1. Patients
with age between 40-60yrs. 2. Sex: Both male and female.
3. Patients fulfilling the diagnostic criteria for Diabetes Mellitus
framed by the AMERICAN DIABETES ASSOCIATION. 3. FBS-126-200mg/dl
PPBS-150-350 mg/dl. 4. HbA1c 7% and more. Patients taking any type of
oral anti-diabetic treatment from 1. Biguanides and 2. Sulfonylurea. Exclusion
criteria involves 1. Patients below the age of 40 years and more
than the age of 60 years, 2. Fasting
Blood Sugar Level <126 mg/dl and >200 mg/dPost Prandial Blood Sugar Level
<180 mg/dl and >350 mg/dl 3. HbA1c
<7%, 4. Patients depending on the insulin for blood glucose
control, 5. Patients with diabetic
complications, 6. Patients suffering from Secondary Diabetes, 7. Gestational
diabetes, 8. Pregnant ladies and
lactating mothers. Assesment criteria involves SUBJECTIVE criterias
are 1. Prabhootmutrata, 2. Avilamutrata, 3. Mutra
Madhuryata, 4. Swapnasheela, Aasansheela, Atikshudha, Atisweda, Daurbalya,
Atitrushna. Objective criteria involves 1. FBS AND PPBS, 2.
Urine (Routine and Microscopic) Patients will be clinically assessed on day 0,1,7,14,21 days for
efficacy and findings would be noted in specified proforma and follow up of the
subjects will be done after 21 days the Haridra Churna with ‘Pippali
Churna’ has been administered. The response of the patient’s diseased
condition will be observed and recorded before, during and after the treatment
in a specially designed case proforma includes detailed history, physical
examination, laboratory investigations and assessment based on subjective and
objective parameters for which appropriate scoring pattern is adopted.Total
duration of study is 42 Days. Duration of Haridra churna
administration is 21 day. Follow up will be done on 42nd day |