| CTRI Number |
CTRI/2021/07/034760 [Registered on: 12/07/2021] Trial Registered Prospectively |
| Last Modified On: |
09/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of Nishalauha and Ferrous Sulphate in the management of Pandu. |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the effect of " Nishalauha with Ferrous Sulphate" in the management of Pandu w. s. r. to Iron Deficiency Anaemia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajesh kumar Manglesh |
| Designation |
Reader Dept of Rog Nidan |
| Affiliation |
Rajiv Gandhi Govt PG College and Hospital Paprola Kangra HP |
| Address |
RGGPG Ayurvedic college and Hospital Paprola Kangra HP 176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9816324204 |
| Fax |
|
| Email |
drrkmanglesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh kumar Manglesh |
| Designation |
Reader Dept of Rog Nidan |
| Affiliation |
Rajiv Gandhi Govt PG College and Hospital Paprola Kangra HP |
| Address |
RGGPG Ayurvedic college and Hospital Paprola Kangra HP 176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9816324204 |
| Fax |
|
| Email |
drrkmanglesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ajay Kumar |
| Designation |
PG Scholar |
| Affiliation |
RGGPG Ayurvedic college and Hospital Paprola Kangra HP |
| Address |
RGGPG Ayurvedic college and Hospital Paprola Kangra HP 176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
7807357678 |
| Fax |
|
| Email |
drajayshukla19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Pharmacy RGGPG Ayurvedic college Paprola Kangra HP.
|
| M/S Shashi Pal Gourav kumar Karyana & Pansari Merchants khoo bazar Paprola Teh baijnath kangra HP |
| Research Institute in I. S. M. Jogindernagar HP |
| Shree Dhootapapershwar limited |
|
|
Primary Sponsor
|
| Name |
Principal RGGPG Ayurvedic college and Hospital Paprola Kangra |
| Address |
RGGPG Ayurvedic college and Hospital Paprola Kangra HP 176115 |
| 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 Rajesh Manglesh |
RGGPG Ayurvedic college and HospitalPaprola |
Room No.711 Dept of Rog RGGPG Ayurvedic college and Hospital Paprola Kangra HP 176115
Kangra
HIMACHAL PRADESH |
9816324204
drrkmanglesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RGGPG Ayurvedic college Paprola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D509||Iron deficiency anemia, unspecified. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ferrous sulphate |
200mg tablet OD for 30 days. |
| Intervention |
Nishalauha |
Tablet form, dose is 500mg OD for 30 days. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having Hemoglobin level 8 to 11 gm%.
Patients of either sex between 12 to 60 years.
Blood picture presenting either Microcytic Hypochromic or Normocytic Hypochromic anaemia.
In pregnancy after 1st trimester. |
|
| ExclusionCriteria |
| Details |
Patients having hemoglobin level less than 8 gm% and more than 11 gm%.
IDA resulting from acute or chronic blood loss.
Patients showing allergy to the trial drug.
Sideroblastic anaemia, thalassemia major and minor.
Anaemia in association with other systemic disorders which interferes with the prognosis and treatment of the case. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fulfilment of objective and subjective criteria. |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
General feeling of wellbeing.
Restoration of the health. |
30 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="20"
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)
|
18/07/2021 |
| 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="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
I would like to publish my research study after completion of the trial as soon as possible. Patients will be selected from opd of RGGPG Ayurvedic college and hospital Paprola kangra HP. Two group of 20 patients will be registered and then assessed on the basis of assessment criteria to know the effect of Niashlauha and ferrous sulphate in the management of Pandu. |