| CTRI Number |
CTRI/2022/06/043613 [Registered on: 30/06/2022] Trial Registered Prospectively |
| Last Modified On: |
29/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Phalatrikadi Kashaya and Kasisa Bhasma in Iron Deficiency Anaemia |
|
Scientific Title of Study
|
Combined effect of Phalatrikadi Kashaya and Kasisa Bhasma in Iron Deficiency Anaemia among menstruating women aged 20-49years |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sreelekshmi R S |
| Designation |
P G Scholar, Department of Rasasastra and Bhaishajya kalpana |
| Affiliation |
Government Ayurveda Medical College Thiruvananthapuram |
| Address |
Government Ayurveda Medical College and Hospital, Pulimoodu junction, Thiruvananthapuram, Kerala 695001
India
Thiruvananthapuram
KERALA
695001
India |
| Phone |
8547316158 |
| Fax |
|
| Email |
sreelekshmirajendra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sreelekshmi R S |
| Designation |
P G Scholar, Department of Rasasastra and Bhaishajya kalpana |
| Affiliation |
Government Ayurveda Medical College Thiruvananthapuram |
| Address |
Government Ayurveda Medical College and Hospital, Pulimoodu junction, Thiruvananthapuram, Kerala 695001
India
Thiruvananthapuram
KERALA
695001
India |
| Phone |
8547316158 |
| Fax |
|
| Email |
sreelekshmirajendra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sreeni T V |
| Designation |
Professor, Department of Rasasastra and Bhaishajya kalpana |
| Affiliation |
Government Ayurveda Medical College Thiruvananthapuram |
| Address |
Government Ayurveda Medical College and Hospital, Pulimoodu junction, Thiruvananthapuram, Kerala 695001
India
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9447500829 |
| Fax |
|
| Email |
drsreenitv@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt Ayurveda Medical College and Hospital, Thiruvananthapuram |
|
|
Primary Sponsor
|
| Name |
Sreelekshmi R S |
| Address |
PG Scholar,Government Ayurveda College and Hospital Pulimoodu Junction Thiruvananthapuram, 695001 |
| Type of Sponsor |
Other [Government Ayurveda Medical College and Hospital, Thiruvananthapuram ] |
|
|
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 |
| Sreelekshmi R S |
Govt.Ayurveda Medical College and Hospital, Thiruvananthapuram |
Department of Rasasastra and Bhaishajya kalpana,Research OP,
Govt Ayurveda Medical College and Hospital,Thiruvananthapuram Pullimood Junction,Thiruvananthapuram, 695001
Thiruvananthapuram
KERALA |
8547316158
sreelekshmirajendra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee{IEC},Govt Ayurveda College,Thiruvananthapuram Kerala,India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D50-D89||Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Phalatrikadi Kashaya, Reference: Sarangadhara Samhitha, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -honey), Additional Information: -(2) Medicine Name: Kasisa Bhasma, Reference: Rasamrtham, Route: Oral, Dosage Form: Bhasma, Dose: 125(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -honey), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
1. Menstruating women of age group 20 to 49 years
2. Hb level between 8 to 12 gm per deci litre
3. Serum ferritin level less than 30 micro gram per
litre
|
|
| ExclusionCriteria |
| Details |
1. Participant with continuous or intermenstrual
bleeding
2. Iron Deficiency Anaemia of chronic disorders
3. Surgery undergone within one month prior to
selection visit or a surgery planned during the
study period
4. Female participants who are pregnant, intends
to become pregnant, breast feeding within two
weeks post partum, having a positive serum or
urine pregnancy test.
5. Participant currently receiving Iron
supplementation
6. Active medical diseases ( acute and chronic
other than anaemia ) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hb level to be measured before and after treatment |
Baseline 0 th day and 31 st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
MCV,Serum ferritin,Serum iron,and TIBC to be measured before and after treatment
Analyze sign and symptoms on the basis of scoring assessment |
0 th day and 31 st day |
|
|
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 3 |
|
Date of First Enrollment (India)
|
01/07/2022 |
| 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="3"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Participant satisfying the selected criteria will be selected. They will be subjected to through physical examination and lab investigation.An informed consent will be obtained from the participant before giving the medicine. 48ml of Phalatrikadi kashaya and 125mg of Kasisa Bhasma along with honey twice daily half an hour before food for continuous period of 30 days will be given to the patient.The participants are requested for review on 15th and 31 st day of medical consumption.
|