| CTRI Number |
CTRI/2018/08/015146 [Registered on: 01/08/2018] Trial Registered Prospectively |
| Last Modified On: |
31/07/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical Use of Drakshwaleha, an ayurvedic medicine in the treatment anemia due to iron deficiency. |
|
Scientific Title of Study
|
Clinical Evaluation of Drakshavaleha in the Management of Pandu (Iron Deficiency Anaemia). |
| Trial Acronym |
DIIDA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr SK Sharma |
| Designation |
Assistant Director (Ayurveda) |
| Affiliation |
Regional Ayurveda Research Institute for Nutritional Disorders |
| Address |
Room No. 1, Ground Floor, Regional Ayurveda Research Institute for Nutritional Disorders, Village Jaral Pandoh, Tehsil Sadar, Distt Mandi, Himachal Pradesh
Mandi
HIMACHAL PRADESH
175124
India |
| Phone |
9418062731 |
| Fax |
|
| Email |
dr.sk.sharma.ad@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikas Nariyal |
| Designation |
Research Officer (Ayurveda) |
| Affiliation |
Regional Ayurveda Research Institute for Nutritional Disorders |
| Address |
Room No. 6, Ground Floor, Regional Ayurveda Research Institute for Nutritional Disorders, Village Jaral Pandoh, Tehsil Sadar, Distt Mandi, Himachal Pradesh
Mandi
HIMACHAL PRADESH
Dr Vikas Nariyal
India |
| Phone |
9509560680 |
| Fax |
|
| Email |
vaidvikas.ayu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vikas Nariyal |
| Designation |
Research Officer (Ayurveda) |
| Affiliation |
Regional Ayurveda Research Institute for Nutritional Disorders |
| Address |
Room No. 6, Ground Floor, Regional Ayurveda Research Institute for Nutritional Disorders, Village Jaral Pandoh, Tehsil Sadar, Distt Mandi, Himachal Pradesh
Mandi
HIMACHAL PRADESH
Dr Vikas Nariyal
India |
| Phone |
9509560680 |
| Fax |
|
| Email |
vaidvikas.ayu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council For Research In Ayurvedic Sciences,
Jawhar Lal Nehru Bhartiya Chikitsa Evam Homeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058 |
|
|
Primary Sponsor
|
| Name |
Central Council For Research In Ayurvedic Sciences |
| Address |
Jawhar Lal Nehru Bhartiya Chikitsa Evam Homeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058 |
| Type of Sponsor |
Other [An Autonomous Body Under Ministry of AYUSH for Research in Ayurveda] |
|
|
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 SK Sharma |
Regional Ayurveda Research Institute For Nutritional Disorders |
Room No. 6, Ayurveda Dept Ground Floor, Regional Ayurveda Research Institute For Nutritional Disorders, Jaral Pandoh, Himachal Pradesh
Mandi
HIMACHAL PRADESH |
9418062731
dr.sk.sharma.ad@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Regional Ayurveda Research Institute For Nutritional Disorders |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D508||Other iron deficiency anemias, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Drakshawleha |
Dose : 10 gmtwice daily (with luke warm water)
Dosage form : Awaleha
Route of Administration : Oral
Time of Administration : Morning and evening before meals
Duration of therapy : 84 days
Follow up without drug : 28 days
Classical Ayurveda Drug.
Drug Reference: AFI-Part-I, 3:15 pg 136,
Ashtang Hridya chikitsasthan 16/29-31 |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE AS SINGLE ARM STUDY |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex aged between18 to 50 years.
2. IDA documented by hematologic indices.
i. Hb 8gm-10gm. %
ii. S.Ferritin < 12 ng /mL
iii. TIBC>450mcg/dL
iv. S.Iron <60μg/dL for male; <50 μg/dL for female
v. MCV<80fL/redcell
vi. RDW>46fL
vii. Reticulocyte count <0.5%
(Among these the first 3 are the essential criteria for inclusion)
3. Willing and able to participate for 112 days.
|
|
| ExclusionCriteria |
| Details |
1. Iron deficiency likely or definitely due to blood loss from the intestine or other sites.
2. History or evidence of intestinal malabsorption
3. Patients suffering from major systemic illness necessitating long term drug
treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, Bleeding
disorders, etc.)
4. Other causes of Anemia (sickle cell disease, thalassemia, other hemolyticAnemia,
bone marrow failure, etc.) apparent by history, physical examination, and/or
laboratory tests.
5. Patients on prolonged (> 6 weeks) medication with corticosteroids,
antidepressants,anticholinergics, etc. or any other drugs that may have an influence
on the outcome of the study.
6. Patients with concurrent serious hepatic disorder (defined as Aspartate
AminoTransferase (AST) and / or Alanine Amino Transferase (ALT), Total
Bilirubin, AlkalinePhosphatase (ALP) > 2 times upper normal limit), or Renal
Disorders (defined as S. Creatinine>1.2mg/dL), Total Serum Cholesterol & / or
Serum Triglycerides > 250 mg/dl, Severe PulmonaryDysfunction (uncontrolled
Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease[COPD]).
7. Alcoholics and/or drug abusers |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in peripheral blood haemoglobin concentration. |
Time Frame: Every 4 weeks (on day 0, 28th,56th,84th and 112th) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Serum Ferritin level,
Serum Iron level,
TIBC level,
MCV level,
Reticulocyte count,
Red blood cell Count,
Any adverse events. |
Time Frame: Every 4 weeks (on day 0, 28th,56th,84th and 112th) |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
07/09/2018 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
will be published in peer reviewed indexed journal with prior permission from the CCRAS |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
An open label, Interventional and Prospective study is proposed for the duration of two years for the clinical assessment of Drakshavaleha in the management of Pandu (Iron Deficiency Anaemia). Sample size of 60 will be randomly drawn from the OPD of RARIND jaral pandoh, Himachal Pradesh. Sample will be assessed by the inclusion criteria and will be treated with 10 gm of Drakshavaleha twice a day before meals with Luke warm water. Patients will be followed on predefined days of the 84 days trial period and will be evaluated for various subjective and objective parameters. Data will be gathered, generated and analysed according to appropriate statistical method. |