| CTRI Number |
CTRI/2011/06/001835 [Registered on: 28/06/2011] Trial Registered Retrospectively |
| Last Modified On: |
05/08/2012 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
Public Title of Study
Modification(s)
|
siddha medicine for PITHA PANDU[Anaemia] |
|
Scientific Title of Study
|
The efficacy of the SIDDHA MANDOORAM [internal] in the treatment of PITHA PANDU [Iron Defeciency Anaemia] |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| 32091202 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrLJanet Sheeba |
| Designation |
M.D(S) student - II year |
| Affiliation |
The T.N.Dr.M.G.R.Medical University, Chennai |
| Address |
Maruthuvam Department,
National Institute of Siddha,
Chennai.
Guindy, Chennai-600032, Tamil Nadu
Chennai
TAMIL NADU
600047
India |
| Phone |
044-22411611 |
| Fax |
044-22381314 |
| Email |
l.janetsheeba@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ProfDrKManickavasakam |
| Designation |
Director |
| Affiliation |
|
| Address |
National Institute of Siddha,
Chennai,
Tamil Nadu
Chennai
TAMIL NADU
600047
India |
| Phone |
044-22411611 |
| Fax |
044-22381314 |
| Email |
dr.kmvm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrNalini Sofia |
| Designation |
Lecturer |
| Affiliation |
|
| Address |
Lecturer,Maruthuvam Department,
National Institute of Siddha,
Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
044-22411611 |
| Fax |
044-22381314 |
| Email |
dr.nalinisofia@gmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| National Institute of Siddha,
Tambaram Sanatorium,
(Department of AYUSH),
Chennai - 600 047,
Tamil Nadu |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha Tambaram SanatoriumDepartment of AYUSH Chennai Tamil Nadu |
| Address |
Chennai - 600047,
Tamil Nadu |
| Type of Sponsor |
Government medical college |
|
Details of Secondary Sponsor
Modification(s)
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrLJanet Sheeba |
National Institute of Siddha |
Maruthuvam Department,National Institute of Siddha-600047
Chennai
TAMIL NADU |
044-22411611
044-22381314
l.janetsheeba@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Of National Institute Of Siddha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
PITHA PANDU [Iron Defeciency Anaemia], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
SIDDHA MANDOORAM |
Kazharchi alavu [2gms],before food,twice a day with buttermilk for 48 days continously |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
patient willing to undergo blood investigation;
Clinical symptoms of:
Pallor
Breathlessness
Palpitation
Anorexia
Giddiness
Lassitude
Fatigue
Koilonychias etc;
Hemoglobin level less than normal range ie.,7-13 mg/dl for men,7-10mg/dl for women[Normal range:Male:14-18gms/dl;Female:11-15gms/dl]Patient blood smear showing Microcytic Hypochromic RBC;
Patient willing to sign the informed consent stating that he/she will conscientiously stick to the treatment during 48 days but can be opt out of the trial of his/her own conscious discretion |
|
| ExclusionCriteria |
| Details |
Parasitic infection;Bleeding disorder[Bleeding piles,Menorrhagia];Pregnancy and lactation;Presence of any associated severe systemic illness[e.g RA,CA];Endocrine disorder[thyroid abnormality,Diabetes mellitus];cardiac disease;Renal disease; H/o of steriod exposure for prolonged time;Peptic ulcer;Gasterctomy;Inherited defects[sickle cell anaemia,Thalassemia];Malabsorption syndrome;Patient not willing to give blood sample. |
|
Method of Generating Random Sequence
Modification(s)
|
Not Applicable |
Method of Concealment
Modification(s)
|
Not Applicable |
Blinding/Masking
Modification(s)
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hemoglobin level |
49th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Reduction in clinical symptoms
2)Changes in complete blood count
3)Changes in Iron supply studies |
Before and After the treatment
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/01/2011 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is a single arm clinical trial evaluting the efficacy of siddha medicine,one of the Indian systems of medicine,as an effective intervention strategy for the disease PITHA PANDU [Iron Defeciency Anaemia].The medicine SIDDHA MANDOORAM is an unique herbo-mineral combination in which the drug Siddha mandooram is administered at a dose of kazharchi alavu[2 gms]orally, before food ,twice a day with buttermilk,to 40 patients included as per inclusion criteria for a period of 48 days with no further administration thereafter.The primary outcome measure of the siddha medicine is increase in Hemoglobin level of the trial patient. The outcome of the trial are given as follows.
Ø Based on the Toxicological studies, 10X dosage [Maximum dose] in
Acute [72 mg/animal] and Chronic toxicity study [720 mg/animal] was found to be
safe in animals, hence the therapeutic dose of Siddha Mandooram [kazharchi alavu- 2 grams] mentioned
in Gunapadam Thaathu Jeeva Vaguppu,Pg-200
is the safety dose level for clinical trial.
Ø From the Biochemical studies, Siddha Mandooram possesses Iron in the
form of Ferrous which is a readily absorbable form of iron and it
is in the amount of 13.859 mg /L.Particle
Per Million of the drug molecule is 5micron.
Ø From the Stastical studies, the Mean ± Standard deviation for Hemoglobin before treatment is 8.835 ± .8929 and after treatment is 9.813 ± 1.3595 which is statistically significant (p <0.05).
Ø From the Clinal studies, it
is clear that PithaPandu noi is caused due to derangement of Pitham followed by
derangement of Vatham and Kabam. Both objective and subjective improvements
were observed in the sample of 40 patients.
Ø The Siddha formulation Siddha Mandooram-2 grams, twice a day with
buttermilk, before meals [Ref: Gunapadam Thaathu Jeeva Vaguppu, pg-200] have
been proved clinically to be haematinic
(75%) and it raises the Haemoglobin level in Anaemic patients when given
regularly for 48 days with specific diet restrictions.
Ø Hence I conclude, the drug Siddha
Mandooram is found to be therepeutically efficacious, and it can be
explored in large sample size and in multicentre trials for further research in
near future.
|