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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  
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 
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  
Status 
Not Applicable 
 
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

 
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