| CTRI Number |
CTRI/2018/09/015869 [Registered on: 28/09/2018] Trial Registered Prospectively |
| Last Modified On: |
16/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study of mustadi kwatha and vangeshwara rasa in the management of madhumeha (Type 2 Diabetes mellitus) |
|
Scientific Title of Study
|
A randomized comparative clinical study to evaluate the efficacy of mustadi kwatha and vangeshwara rasa in the management of madhumeha w.s.r. to 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 |
Dr Hari Khanal |
| Designation |
MD Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
PG Department of Kayachikitsa National Institute of Ayurveda,Madhav Vilas Palace,Jorawar Singh Gate Jaipur,Rajasthan.
Jaipur RAJASTHAN 302002 India |
| Phone |
8875712514 |
| Fax |
|
| Email |
khanalhari061@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prof Ram Kishor Joshi |
| Designation |
Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
PG Department of Kayachikitsa National Institute of Ayurveda,Madhav Vilas Palace,Jorawar Singh Gate Jaipur,Rajasthan.
Jaipur RAJASTHAN 302002 India |
| Phone |
9414322297 |
| Fax |
|
| Email |
joshirk1964@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Hari Khanal |
| Designation |
MD Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
PG Department of Kayachikitsa National Institute of Ayurveda,Madhav Vilas Palace,Jorawar Singh Gate Jaipur,Rajasthan.
Jaipur RAJASTHAN 302002 India |
| Phone |
8875712514 |
| Fax |
|
| Email |
khanalhari061@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda, Madhav Vilas Palace Jorawor Sing Gate, Jaipur Rajasthan. |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
Madhav Vilas Palace,Jorawar Sing Gate,Jaipur,Rajasthan |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Hari Khanal |
PG Department of Kayachikitsa, National
Institute of Ayurveda,Madhav Vilas Palace,
Jorawar Singh Gate,Jaipur,Rajasthan |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Hari Khanal |
National Institute of Ayurveda |
Kayachikitsa Department OPD/Room No.-1,7,18 and 25.Madhav Vilas Palace,Jorawar Singh Gate,Jaipur,Rajasthan Jaipur RAJASTHAN |
8875712514
khanalhari061@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, National Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A |
In this group 15 patients will be administered trial drug mustadi kwatha orally in the dose of 50 ml twice a day before meals for 45 days. |
| Intervention |
Group B |
In this group 15 patients will be administered vangeshwara rasa 250 mg orally twice a day before meals for 45 days with lukewarm water. |
| Intervention |
Group C |
– In this group 15 patients will be administered 50 ml mustadi kwatha (before meals) along with 250 mg vangeshwara rasa (before meals) orally twice a day for 45 days. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient willing to sign the consent form.
2. Patients in the age group of 30-70 years.
3. Patients with Fasting Blood Sugar (FBS) in the range of 126mg/dl – 250mg/dl or Post Prandial Blood Sugar (PPBS) in the range of 200mg/dl – 300 mg/dl and Glycosylated Haemoglobin (HbA1c) 6.5% - 9.0% .
|
|
| ExclusionCriteria |
| Details |
1. Patients below 30 years & above 70 years of age.
2. Patients having Type 1 DM.
3. Patients of Type 2 DM who are on insulin therapy.
4. Patients having any serious illness like coronary artery disease, malignancy, kidney failure etc.
5. Patient whose Fasting Blood Sugar (FBS) > 250 mg/dl or Post Prandial Blood Sugar (PPBS) > 300 mg/dl or Glycosylated Haemoglobin (HbA1c) > 9.0%.
6. DM with complications.
7. Pregnant women and lactating mother. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of changes in Blood Sugar Level (FBS,PPBS) and specific signs and symptoms of Madhumeha (Type 2 Diabetes Mellitus) |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Any adverse effect in the values of hematological test and in clinical signs and symptoms. |
45 days |
|
|
Target Sample Size
|
Total Sample Size="45" Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="48" |
|
Phase of Trial
|
Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
30/11/2019 |
| Date of Study Completion (India) |
22/03/2020 |
| Date of First Enrollment (Global) |
30/11/2019 |
| Date of Study Completion (Global) |
22/03/2020 |
|
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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Diabetes
Mellitus (DM) is a clinical syndrome characterised by hyperglycaemia due to
absolute or relative deficiency of insulin. Diabetes Mellitus is classified
into two broad categories: Type 1 DM and Type 2 DM. Type 1 DM is a result of
absolute deficiency of insulin while Type 2 DM is a heterogeneous group of
disorders characterised by variable degrees of insulin resistance, impaired
insulin secretion and increased glucose production. Diabetes
Mellitus usually presents with symptoms like polyuria, polydipsia and
polyphagia. Over time, DM can damage the heart, blood vessels, eyes, kidneys
and nerves. According to aetiological factors, pathogenesis and clinical
features, Diabetes mellitus can be correlated with Madhumeha in Ayurveda. Madhumeha is the result of untreated Prameha. It is Vataja
Prameha where the Vata depletes all Dhatu except Asthi
Dhatu and Oja by excreting them through urine leading
to Prabhuto Avila Mutrata.Although new drugs and therapeutics are emerging for the management of
Diabetes Mellitus (DM), its prevalence is increasing at an alarming rate. DM does not come alone it brings
with itself various acute and chronic metabolic complications of hyperglycaemia
affecting every organ from head to toe. Once an individual is diagnosed with DM the dosage of medicine is ever
increasing and ultimately insulin has to be given for glycemic control in most
of the cases. Ayurveda has a great potential in
the management of Madhumeha (Type 2 DM) and its
associated complications.This study finds that Type 2 diabetes mellitus is more prevalent in the
elderly population. More specifically, the prevalence of disease is more in 4th, 5th, and 6th decade of life. This
finding is consistent with many other studies across different parts of the
world. Similarly, the prevalence of disease is more in patients with
sedentary life, lack of exercise and faulty food habits in comparison with the
patients performing regular physical activity and having regular healthy diet. Thus, the results of this study imply that
food and exercise play a major role in controlling the blood glucose
level. Another interesting findings of this study is that only a few of
the 45 registered patient have a classical symptoms of the disease whereas most
of the patient are symptomless, but those patients were having a high blood
sugar level. This suggests the need of regular medical check-up the elderly
people because these people might have been affected by the disease even if
they do not show any related symptoms. In the
present study both Mustadi Kwatha and Vangeshwara Rasa reduce many symptoms
of Madhumeha (Diabetes Mellitus) that
include Prabhoota Mutrata (Polyuria), Avila Mutrata (Turbidity), Trishnadhikya (Excessive Swaeting), Kara Pada Supti (Numbness of Extremities) and Daurbalya (Weakness) significantly. While in Kara Pada Daha (Burning sensation in
hands and Feet) and in Kshudadhikya (Polyphagia) minimum
improvement was observed. The
sample size of this study may not be adequate to determine the effectiveness of
the drugs in some variables like Avila Mutrata, Karapada Daha and Kshudhadhikya which are present in fewer
patient. Regarding overall improvement
in objective parameters, Vangeshwara Rasa alone and in combination with Mustadi Kwatha provide highly significant p<0.001 reduction in FBS and PPBS, While Mustadi Kwatha provide significant
p<0.05 reduction in FBS and PPBS. The trial drug Mustadi Kwatha is more effective in
reducing serum cholesterol and triglyceride in comparison to Vangeshwara Rasa. Similarly, Vangeshwara Rasa have shown significant
increment in HDL as compare to Mustadi Kwatha. These
results suggest the positive effect of the trial drugs in this study. The results were
non-significant in parameters like SGOT, SGPT, Blood Urea, Serum Creatinine,
Urine protein. They were within normal range after 45 days of administration of
these drugs. The findings imply that there were no any adverse effect of these
drugs. Diabetes is often associated with obesity, dyslipidaemia,
hypertension, insulin resistance, known as metabolic syndrome.
From the
present study we can say that both the drug Mustadi Kwatha and Vangeshwara in combined form are capable
to handle Diabetes as well as its associated condition. |