| CTRI Number |
CTRI/2024/06/068815 [Registered on: 12/06/2024] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [other] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to evaluate the efficacy of Nishalauha and Vasaadi Kwatha in Pandu Roga |
|
Scientific Title of Study
|
A clinical study to evaluate the efficacy of Nishalauha and Vasaadi Kwatha in the management of Pandu Roga w.s.r. to Iron deficiency Anaemia |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Anjana Mishra |
| Designation |
Head of the Department |
| Affiliation |
Rajiv Gandhi Govt. Post Graduate Ayurvedic College and Hospital |
| Address |
Room Number 317 Hospital building Rajiv Gandhi Government Ayurvedic College and Hospital Paprola District Kangra
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
7018101789 |
| Fax |
|
| Email |
dranjana269@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geetika Dharmani |
| Designation |
Ayurvedic medical officer |
| Affiliation |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and hospital Paprola |
| Address |
Room Number 317 Hospital building Rajiv Gandhi Government Ayurvedic College and Hospital Paprola District Kangra
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
7018817072 |
| Fax |
|
| Email |
Dr.geeti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prerna |
| Designation |
P. G. Scholar |
| Affiliation |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and hospital, Paprola |
| Address |
Room Number 317 Hospital building Rajiv Gandhi Government Ayurvedic College and Hospital Paprola District Kangra
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9459865777 |
| Fax |
|
| Email |
priyaprarthi7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Ayurvedic Pharmacy Paprola Kangra Himachal Pradesh India 176115 |
|
|
Primary Sponsor
|
| Name |
Principal Rajiv Gandhi Government Ayurvedic College and Hospital Paprola District Kangra |
| Address |
Rajiv Gandhi Government Ayurvedic College and Hospital Paprola District Kangra Himachal Pradesh India 176115 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Prof Anjana Mishra |
RAJIV GANDHI GOVT POST GRADUATE AYURVEDIC COLLEGE & HOSPITAL PAPROLA DISTT KANGRA (HP) 176115 |
Room Number 317 Hospital building Rajiv Gandhi Government Post Graduate Hospital Paprola District Kangra Himachal Pradesh 176115
Kangra
HIMACHAL PRADESH |
7018101789
dranjana269@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Nishalauha, Reference: bhaishajya ratnavali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: luke warm water), Additional Information: -(2) Medicine Name: Vasaadi Kwatha, Reference: Bhaishajya ratnavali, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Tab Ferrous Sulphate | Tab Ferrous sulphate will be given in the dose of 100mg once a day 2 hours after meals for 8 weeks |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with signs and symptoms of pandu roga having haemoglobin 8-12gm% in males and 8-11gm% in females. |
|
| ExclusionCriteria |
| Details |
patients suffering from chronic respiratory cardiac renal disorders, Diabetes mellitus, pregnant and lactating mothers , CA, TB |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Increase in haemoglobin concentration
|
patients will be assess after 4 weeks and at the end of trial. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Assess the clinical safety & untoward effects of Nishalauha & Vasaadi Kwatha in the management of Pandu Roga w.s.r. to Iron Deficiency Anaemia |
8 weeks |
|
|
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 4 |
|
Date of First Enrollment (India)
|
01/09/2024 |
| 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="0"
Months="2"
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
Modification(s)
|
I would like to publish my work after completion of my research work as soon as possible. Patients will be selected from OPD/IPD of R. G. G. P. G. Ayurvedic College, Paprola. 30 Patients will be divided into 2 groups and a comparative study will be done to study the efficacy of Nishalauha and Vasaadi Kwatha in the management of Pandu Roga w.s.r. to Iron Deficiency Anaemia. |