| CTRI Number |
CTRI/2024/12/077663 [Registered on: 04/12/2024] Trial Registered Prospectively |
| Last Modified On: |
28/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [therapeutic] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Nishalauh vati in comparison with
Iron tablets in Panduroga w.r.t. Iron Deficiency Anemia in females. |
|
Scientific Title of Study
|
A Randomized controlled trial of Nishalauh vati in comparison with
Iron tablets in Panduroga w.r.t. Iron Deficiency Anemia in females. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Snehal Bhimarao kamble |
| Designation |
PhD Scholar |
| Affiliation |
Goverment Ayurved College |
| Address |
Goverment Ayurved college, Department of Prasutitantra Streerog,2nd Floor, Raje Raghuji Nagar, Umred Road,Sakkardara Chowk, Nagpur
Nagpur
MAHARASHTRA
440024
India |
| Phone |
7709496089 |
| Fax |
|
| Email |
snehalkamble3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anita Bombarde |
| Designation |
Professor & HOD( PhD Guide) |
| Affiliation |
Goverment Ayurved College, Nagpur |
| Address |
Goverment Ayurved collegeand Hospital, department of Prasutitantra Streeroga, 2nd floor, Raje Raghuji Nagar, Umred Road, Nagpur
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9970115160 |
| Fax |
|
| Email |
dr.adbombarde67@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Snehal Bhimarao kamble |
| Designation |
PhD Scholar |
| Affiliation |
Goverment Ayurved college , Nagpur |
| Address |
Goverment Ayurved collegeand Hospital, department of Prasutitantra Streeroga, 2nd floor, Raje Raghuji Nagar, Umred Road, Nagpur-440024
Nagpur
MAHARASHTRA
440024
India |
| Phone |
7709496089 |
| Fax |
|
| Email |
snehalkamble3@mail.com |
|
|
Source of Monetary or Material Support
|
| Goverment Ayurved college and Hospital, Raje Raghuji Nagar, Umred Road, Nagpur-440024 |
|
|
Primary Sponsor
|
| Name |
Dr snehal Bhimarao Kamble |
| Address |
Goverment Ayurved collegeand Hospital, department of Prasutitantra Streeroga, 2nd floor, Raje Raghuji Nagar, Umred Road, Nagpur-440024 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Bhausaheb mulak Ayurved college and Resaerch hospital Butibori |
P-73,R&C zone, MIDC, Butibori 441122 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr snehal Bhimarao Kamble |
Bhausaheb mulak Ayurved college and Resaerch hospital Butibori |
P-73 R&C zone MIDC Butibori 441122
Nagpur
MAHARASHTRA |
7709496089
snehalkamble3@gmail.com |
| Dr snehal Bhimarao Kamble |
Goverment Ayurved College , Nagpur |
OPD No42, Streeroga prasutitantra OPDGoverment Ayurved collegeand Hospital, department of Prasutitantra Streeroga, 2nd floor, Raje Raghuji Nagar, Umred Road, Nagpur-440024
Nagpur
MAHARASHTRA |
7709496089
snehalkamble3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| IEC BMAC&RH Butibori |
Approved |
| IEC goverment ayurved college Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D508||Other iron deficiency anemias. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | tab iron folic acid | it is iron folic acid tablet give for 90days. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
1.Female Patients having symtoms of pandu as describe in classical ayurveda, Hb 8 to 10gm/dl, Haematocrit less than 30%.
2.Female Patients willing to participate in the trial. |
|
| ExclusionCriteria |
| Details |
1.Female Patients having Hb less than 8gm/dl
2.Pregnant females and lactating mothers.
3. Anemia due to other pathology like cardiac, renal, liver disorders, diabetes mellitus, hypertension, thalassaemia, sickle cell anemia, rhumatoid arthritis, worm infestation, acute and chronic blood loss, bleeding disorders
hemoglobinopathies and malignancy and defective absorption like patients of gastrectomy, gastrojejunostomy et
4.Female Patients of age less than 18 and above 49 years of life. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of Nishalauh vati & tab iron
folic acid in the managment of panduroga w.r.t iron Deficiency Anemia |
day 0, day 30, day 60, day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effect of Nishalauh vati & tab Iron folic acid on overall improvment of Panduroga w.r.t iron deficiency anemia by subjective criteria. |
Effect of Nishalauh vati & tab Iron folic acid on overall improvment of Panduroga w.r.t iron deficiency anemia by subjective criteria treatment day 0 , day 30, day 60 & day 90. |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/12/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is randomized, open labelled, controlled clinical trail to compare the efficacy of Nishalauh Vati and tab iron folic acid in panduroga w.r.t Iron Deficiancy anemia in females for 90 days in patients of age 18 to 49 years having hb 8 to 10 gm/dl. The primary outcome measures will be relief from subjective and objective parameters before and after treatment on 90th day.The secondory outcome measures will be overall improvement of Hb on 0day, 30 day,60 day, 90day. The result obtained wii be analysed statistically to draw conclusion from the study. |