| CTRI Number |
CTRI/2013/05/003705 [Registered on: 30/05/2013] Trial Registered Retrospectively |
| Last Modified On: |
06/08/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A comparative clinico-experimental evaluation of Rasayana Drugs administered orally & by Basti in the management of Madhumeha w. s. r. to Type-II Diabetes Mellitus |
|
Scientific Title of Study
|
A comparative clinico-experimental evaluation of Rasayana Drugs administered orally & by Basti 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 |
Swapnil Shivaji Auti |
| Designation |
Ph.D. Scholar |
| Affiliation |
Institute for Post Graduate Teaching & Research in Ayurveda, Gujarat Ayurved University |
| Address |
Department of Panchakarma,
I.P.G.T. & R.A., Gujarat Ayurved University,
Jamnagar-361008
B/16, staff colony, Gujarat Ayurved University, jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9277404342 |
| Fax |
|
| Email |
swapn.punarvasu@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anup B Thakar |
| Designation |
Associate Professor & I/C Head dept. of Panchakarma |
| Affiliation |
Institute for Post Graduate Teaching & Research in Ayurveda, Gujarat Ayurved University |
| Address |
Department of Panchakarma,
I.P.G.T. & R.A., Gujarat Ayurved University,
Jamnagar-361008
Jamnagar
GUJARAT
361008
India |
| Phone |
9427776660 |
| Fax |
|
| Email |
anup_thakar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Swapnil Shivaji Auti |
| Designation |
Ph.D. Scholar |
| Affiliation |
Institute for Post Graduate Teaching & Research in Ayurveda, Gujarat Ayurved University |
| Address |
Department of Panchakarma,
I.P.G.T. & R.A., Gujarat Ayurved University,
Jamnagar-361008
B/16, staff colony, Gujarat Ayurved University, jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9277404342 |
| Fax |
|
| Email |
swapn.punarvasu@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Institute for post graduate teaching and research in Ayurveda, Gujarat Ayurved University, Jamnagar |
|
|
Primary Sponsor
|
| Name |
Institute for post graduate teaching and research in Ayurveda Gujarat Ayurved University Jamnagar |
| Address |
Institute for post graduate teaching and research in Ayurveda, Gujarat Ayurved University, Jamnagar |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr A B Thakar |
Institute for post graduate teaching and research in Ayurveda, Gujarat Ayurved University, Jamnagar. |
OPD no. 20, Department of Panchakarma, Institute for post graduate teaching and research in Ayurveda, Gujarat Ayurved University, Jamnagar.
Jamnagar
GUJARAT |
9427776660
anup_thakar@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee , IPGT & RA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Type 2 Diabetes Mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Basti |
Madanaphala Taila Anuvasana 160 ml followed by three Rasayana Basti each of 9 Prasruta (Approx. 850ml) & one Anuvasana on last day; in a schedule of 21 days |
| Comparator Agent |
Placebo |
Placebo capsule containing barley powder, one capsule of 500 mg twice a day for 21 days |
| Intervention |
Rasayana Kashaya |
Rasayana Kashaya in a dose of 100ml daily in two divided doses before meal for 21 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient of NIDDM with blood sugar level,
FBS- 126 to 220 mg/dl or
PPBS- 180 to 300 mg/dl.
|
|
| ExclusionCriteria |
| Details |
Patients having age less than 20 years & above 60 years.
Patients of Type-I Diabetes or the patients of Type-II Diabetes taking Insulin.
Patients having complications of Diabetes like Nephropathy, Retinopathy, Diabetic Foot, Carbuncles etc.
Patients having Diabetes in association with other endocrinopathies like Phaeochromocytoma, Acromegaly, Cushing’s syndrome, hyperthyroidism etc.
Patients having drug or chemical induced Type II Diabetes, like glucocorticoids induced or thyroid hormone induced etc.
Patients with genetic syndromes associated with Type II Diabetes like Down’s Syndrome, Klinefelter’s Syndrome, Turner’s Syndrome etc.
Patients complicated with any Cardiovascular diseases, Renal diseases, Carcinoma or any other disease effecting multiple body systems and pregnant women etc.
Patients contraindicated for Bastikarma as per classics
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| blood sugar reduction and reduction in sign and symptoms of diabetes mellitus type 2 |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reduction in sign and symptoms of Madhumeha |
21 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
26/06/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
In present clinical trial patient fulfilling inclusion
criteria were
randomly divided into three groups viz; group A in which Madanaphala Taila
Anuvasana 160 ml followed by three
Rasayana Basti each of 9 Prasruta (850ml) & one Anuvasana on last day; in a
schedule of 21 days was given; second group B in
which Rasayana Kashaya in a
dose of 100ml daily in two divided doses before
meal for 21 days was given & in group C placebo capsule of
500 mg twice a day for 21 days was given. Total 91 (91%)
patients, i.e. 30 in group A, 30 in group B and 30 in group C completed the
course of the therapy. Rasayana Basti has
shown 54.55% decrease in polyurea, 50% in turbidity of urine, 53.49% in
polyphagia, 60.87% in polydypsia, 90.91% in leg cramps, 69.57% in burning
sensation, 68.75% in numbness, 58.54% in excess sweating, 75% in dryness of
mouth, 65.52% in the weakness, 67.57% in fatigue, 1.72% in the weight loss
& 55.56% in the loss of libido. Rasayana Kashaya has shown 54.90% decrease
in polyurea, 50% in turbidity of urine, 52.38% in polyphagia, 60% in
polydypsia, 72.22% in leg cramps, 57.58% in burning sensation, 55.56% in
numbness, 50% in excess sweating, 100% in dryness of mouth, 58% in the
weakness, 65.52% in fatigue, 1.02% in the weight loss & 50% in the loss of
libido. Placebo failed to give any relief however the symptoms aggravated by
the placebo treatment. In patients treated with Rasayana Basti there was a
decrease of 5.4% & 6.36% in FBS & PPBS respectively. These changes were
statistically insignificant (p>0.05). In group B there was a statistically
significant (p<0.05 & p<0.01 respectively) decrease of 13.02% &
21.60% in FBS & PPBS respectively. In group C there was a statistically
insignificant (p>0.05) increase of 8.22% in FBS. However, in PPBS 20.62%
increase was seen which was statistically significant (p<0.01). Results suggest that Rasayana Kashaya is superior in glycemic control as compared to Rasayana
Basti. However clinical manifestations of Madhumeha are well managed with both Rasayana Basti & Kashaya |