| CTRI Number |
CTRI/2019/12/022494 [Registered on: 23/12/2019] Trial Registered Prospectively |
| Last Modified On: |
02/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical evaluation of the effect of siddha classical drug ASUVAATHI CHOORANAM for the treatment of ANEMIA. |
|
Scientific Title of Study
|
Clinical evaluation of the effect of ASUVAATHI CHOORANAM for the treatment of MANNUN VELUPPU NOI |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manimegalai R |
| Designation |
Post Graduate Student |
| Affiliation |
Government siddha medical college and hospital ,palayamkottai. |
| Address |
Department of kuzhanthai maruthuvam,
Government siddha medical college and hospital,
Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8760072649 |
| Fax |
|
| Email |
maniramk94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Soundararajan D K |
| Designation |
Professor and Head of the Department |
| Affiliation |
Government siddha medical college and hospital |
| Address |
Department of kuzhanthai maruthuvam,
Government siddha medical college and hospital,
Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9442048801 |
| Fax |
|
| Email |
dr.dks.2012@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Soundararajan D K |
| Designation |
Professor and Head of the Department |
| Affiliation |
Government siddha medical college and hospital |
| Address |
Department of kuzhanthai maruthuvam,
Government siddha medical college and hospital,
Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9442048801 |
| Fax |
|
| Email |
dr.dks.2012@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government siddha medical college and hospital, palayamkottai, Tirunelveli- 627002 |
|
|
Primary Sponsor
|
| Name |
Manimegalai R |
| Address |
Department of kuzhanthai maruthuvam,
Government siddha medical college and hospital,
Palayamkottai,
Trunelveli,
Tamilnadu,
627002. |
| Type of Sponsor |
Other [self] |
|
|
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 |
| R Manimegalai |
Government siddha medical college and hospital, palayamkottai |
Department of kuzhanthai Maruthuvam
Government siddha medical college and hospital
palayamkottai
Tirunelveli-627002
Tamil Nadu
Tirunelveli
TAMIL NADU |
8760072649
maniramk94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Government Siddha Medical College, Palyamkottai, Tirunelveli-627002, Tamil Nadu, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D509||Iron deficiency anemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ASUVAATHI CHOORANAM |
should be administered orally twice a day after food along with fresh buffalo whey for a period of 48 days
dose: 500mg |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with any of the following symptoms will be included in the study
1. Hb level between 7 to 10gms
2. pallor of skin, tongue, mucus membrane, conjunctiva and nail buds
3. Fatigue, palpitation, breathlessness
4. Anemia due to iron deficiency, worm infestations, pica |
|
| ExclusionCriteria |
| Details |
Following symptoms will be excluded in this study
1. Children above 12 years
2. Hb less than 7grams
3.Anemia due to bleeding disorders and nephritis
4. Sickle cell anemia, thalassemia, sideroblastic anemia, Aplastic anemia
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reducing the symptoms of 1.Pallor of skin, mucous membrane,tongue and nail buds
2.Palpitation, Breathlessness, Fatigue, Anorexia |
after 2nd weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemoglobin count |
from 6th weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
30/12/2019 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is a single arm clinical trial to determine the safety and efficacy of ASUVAATHI CHOORANAM in patients with MANNUN VELUPPU NOI. |