| CTRI Number |
CTRI/2019/06/019627 [Registered on: 11/06/2019] Trial Registered Prospectively |
| Last Modified On: |
08/06/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To See the efficacy of Katankateryadi kwatha and Indra Vati in the management of Madhumeha (Diabetes mellitus) |
|
Scientific Title of Study
|
A clinical study to evaluate efficacy of Katankateryadi kwatha and Indra Vati in the management of Madhumeha w.s.r. to Type II 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 Deepak Suman |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
PG Department of Kayachikitsa, National Institute of Ayurveda, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
7568396094 |
| Fax |
|
| Email |
drdeepaksuman11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Ram Kishor Joshi |
| Designation |
Professor and HOD |
| Affiliation |
National Institute of Ayurveda |
| Address |
PG Department of Kayachikitsa, National Institute of Ayurveda, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
9414322297 |
| Fax |
|
| Email |
joshirk1964@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harish Bhakuni |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
PG Department of Kayachikitsa, National Institute of Ayurveda, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
7891233108 |
| Fax |
|
| Email |
harishbhakuni78@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda, Jaipur, Rajasthan, 302002 |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda Jaipur |
| Address |
Near Jorawar Singh Gate, Madhav Vilas palace, Amer Road, Jaipur, Rajasthan, 302002 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Deepak Suman |
National Institute of Ayurveda Hospital |
OPD No. 1,7,18,25 and IPD No. 16,112,140 of PG Department of Kayachikitsa
Jaipur
RAJASTHAN |
7568396094
drdeepaksuman11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, National Institute of Ayurveda, Jaipur, Rajasthan |
Approved |
|
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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 |
| Intervention |
Indra Vati |
Patients in Group B will be administered Indra Vati 125 mg twice a day after meal for 30 days with luke warm water. |
| Intervention |
Katankateryadi Kwatha |
Patients in Group A will be administered Trial Drug Katankateryadi Kwatha in the dose of 50 ml BD before meal for 30 days. |
| Intervention |
Katankateryadi Kwatha and Indra Vati |
Patients in Group C will be administered both Katankateryadi Kwatha and Indra Vati for 30 days. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
i.Patient willing to sign the consent form.
ii.Patients between the ages of 30-70 years of either sex.
iii.Patients giving the clinical history of DM (Type II).
iv.Patients having hyperglycemia confirmed by laboratory investigations i.e. Fasting Blood Sugar (FBS) ≥ 126mg/dl or Post Prandial Blood Sugar (PPBS) ≥ 200mg/dl or Glycosylated Hemoglobin (HbA1c) ≥ 6.5%.
v.Presence of Cardinal symptoms of Diabetes Mellitus eg. (3P- polyuria, polydypsia, polyphagia). |
|
| ExclusionCriteria |
| Details |
i.Patients below 30years of age & above 70 years of age.
ii.Patients having Type I DM.
iii.Patients of Type II DM who are on insulin therapy.
iv.Patients having any serious illness like Coronary Artery Disease, malignancy, etc.
v.Drug induced DM.
vi.F.B.S. > 200 mg/dl and P.P.B.S. > 300 mg/dl.
vii.Patients having chronicity of more than 5 years.
viii.DM with complications.
ix.Pregnant and lactating mother. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of changes in
specific signs and symptoms of Madhumeha and Type II Diabetes Mellitus |
30 days for Each Patients |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Any adverse effect in the
values of haematological test and in clinical
signs and symptoms. |
30 days for Each Patients |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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 2 |
|
Date of First Enrollment (India)
|
18/06/2019 |
| 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="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Still Under Process |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Aims and Objectives: To assess the efficacy of Katankateryadi Kwatha and Indravati in the management of Madhumeha (DM Type II). Selection of Cases: Study will be conducted in 45 clinically diagnosed and confirmed patients of Madhumeha (Type II Diabetes Mellitus) from OPD/IPD of Arogyashala NIA, Jaipur. These patients will be randomly divided into three groups - Group A, Group B and Group C with 15 patients in each group. Study Design: Open label, Randomized, Single Centre Administration of Drug: Patients in Group A will be administered Trial Drug Katankateryadi Kwatha in the dose of 50 ml BD before meal for 30 days. · Patients in Group B will be administered Indra Vati 125 mg twice a day after meal for 30 days with luke warm water. Patients in Group C will be administered both Katankateryadi Kwatha and Indra Vati for 30 days. Criteria for Assessment: The effect of trial drug will be assessed in following subjective and objective parameters - Subjective Parameter: Prabhoot mutrata (Polyuria), Kshudhadhikya (Polyphagia), Trishnadhikya (Polydypsia), Klama (Early Fatigue), Mukha Shosha (Dryness of mouth), Vibandha (Constipation), Kara pada daha (Burning sensation in hands and feet), Hasta pada and sandhi shoola (Pain in hands, feet and joints), Kara pada supti (Numbness of hands and feet), Daurbalya (Weakness) Objective Parameter: Complete Blood Count (C.B.C.), Erythrocyte sedimentation rate (E.S.R), Fasting Blood Sugar (F.B.S), Post Prandial Blood Sugar (P.P.B.S), Glycosylated Hemoglobin (HbA1c), Blood Urea, Sr. Creatinine, S.G.P.T and S.G.O.T, Lipid Profile, Urine Examination-Routine and Microscopic examination. Routine Examination & Assessment: The full details of history & physical examination of patient will be recorded as per the Performa. Clinical assessment will be done on 1st day, 15th day and 30th day.
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