| CTRI Number |
CTRI/2020/04/024459 [Registered on: 03/04/2020] Trial Registered Prospectively |
| Last Modified On: |
26/03/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study of Darvyadi Granules in Iron Deficiency Anaemia. |
|
Scientific Title of Study
|
Pharmaceutical Analytical and Interventional study of Darvyadi Granules in Iron Deficiency Anaemia-A Pilot Study |
| Trial Acronym |
DGIDA-19 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AnithaH |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurved and Research |
| Address |
Department of Rasashastra and BK
Parul Institute of Ayurved and Research
Ishwarapura Waghodia
Parul Institute of Ayurveda and Research
Vadodara
GUJARAT
391760
India |
| Phone |
9739624874 |
| Fax |
|
| Email |
docvaishnavi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
AnithaH |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurved and Research |
| Address |
Professor Department of Rasashastra and BK
Parul Institute of Ayurved and Research
Ishwarapura Waghodia
Parul Institute of Ayurveda and Research
Vadodara
GUJARAT
391760
India |
| Phone |
9739624874 |
| Fax |
|
| Email |
docvaishnavi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
AnithaH |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurved and Research |
| Address |
Department of Rasashastra and BK
Parul Institute of Ayurved and Research
Ishwarapura Waghodia
Parul Institute of Ayurveda and Research
Vadodara
GUJARAT
391760
India |
| Phone |
9739624874 |
| Fax |
|
| Email |
docvaishnavi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul University, Limda, Waghodia,Vadodara-391760, Gujarat, |
|
|
Primary Sponsor
|
| Name |
Parul University |
| Address |
Limda Waghodia Vadodara Gujarat |
| 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 Anitha H |
Parul Institute of Ayurved and Research |
Department of Rasshastra and Bhaishajya kalpana,Teaching Pharmacy, Room No. 106 Ishwarpura waghodia vadodara Gujarat
Vadodara
GUJARAT |
9739624874
docvaishnavi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIAR-IECHR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D508||Other iron deficiency anemias, (2) ICD-10 Condition: D508||Other iron deficiency anemias, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Darvyadi Granules orally |
10 gm twice in a day with warm water after food for 3 months |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient fulfilling screening parameters.
Age limit 18-70 years irrespective of religion, socioeconomic, marital status and gender
Hb% - Between 8 gm% and 11gm%
|
|
| ExclusionCriteria |
| Details |
Anemia other than Iron deficiency anemia, Sickle cell anemia.
Patients suffering from systemic disorders like tuberculosis, HIV, Leprosy and any malignancies.
Pregnant and Lactating Woman.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. New modifieddosage form of Darvyadi Churna will be introducedin clinical practice which will be suitable for all age groups from paediatric to Geriatric.
2. This particular form of medicine is not available and is also cost effective.
3. The study may throw up effective remedy for treating Iron Deficiency Anaemia thus benefiting the population suffering from the disease.
|
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
2. This particular form of medicine is not available and is also cost effective.
3. The study may throw up effective remedy for treating Iron Deficiency Anaemia thus benefiting the population suffering from the disease.
|
18 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 1 |
|
Date of First Enrollment (India)
|
17/04/2020 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Anaemia is a major public health concern in India and
20% of the population suffer globally. The major cause of the disease is
recognized as Iron deficiency. In the present project objective of the study will
be to evaluate the efficacy of Darvyadi Granules in Iron deficiency anaemia in
human subjects. In Panduroga Rogadhikara
of Charak Samhita, Darvyadi churna is mentioned which is indicated in Yakrit
Vikara and Panduroga. It includes 9 ingradients namely Triphala, Trikatu,
Darvi, Vidanga and Lauha Bhasma. In the present work this formulation is
modified to Darvyadi Granules for better acceptability and palatability to the
patients. Darvyadi Granules will be prepared in the teaching Pharmacy, PIAR.
Raw materials and final product quality assessment will be done in recognized
analytical laboratories.
It
is an open labeled single centric clinical trial.As it is
a pilot study, sample size of 30 subjects irrespective of race, gender,
occupation, socio economic status will be considered. The subjective parameters
such as Pallor,Shortness
of Breath, Fatigue, Palpitation, and Dizziness will be assessed. Hb%, Complete Blood Count, Serum
Ferritin, Total Iron Binding Capacityand Peripheral
Smear of the patient will be investigated to observe the effect. Patients will
be screened for the study based on subjective parameters Hb% and MCV. Patients
will be on treatment with trial drug for a period of 3 months and observation
will be done on every 15th day. The duration of the project will be
18 months which includes preparation of the medicine, screening of the patients
and treatment period of 90 days. The observations will be statistically
analyzed and documented. |