| CTRI Number |
CTRI/2025/01/079212 [Registered on: 22/01/2025] Trial Registered Prospectively |
| Last Modified On: |
21/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Therapeutic clinical] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of effect of Ashtadashang Lauha and Dhatri Lauha in Pandu Roga[ Iron Deficiency Anaemia] |
|
Scientific Title of Study
|
A Randomized Controlled Study to compare the efficacy of Ashtadashang Lauha and Dhatri Lauha in 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 |
Anushka Abhay Singh |
| Designation |
MD Scholar, Kayachikitsa |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
PG Department of Kayachikitsa, Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, Najafgarh, New Delhi
South West
DELHI
110073
India |
| Phone |
8377095512 |
| Fax |
|
| Email |
anushkasingh9september@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajendra Kumar Soni |
| Designation |
Assistant Professor, Kayachikitsa |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
PG Department of Kayachikitsa, Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, Najafgarh, New Delhi
South West
DELHI
110073
India |
| Phone |
8506964826 |
| Fax |
|
| Email |
dr.rajendrasoni@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajendra Kumar Soni |
| Designation |
Assistant Professor, Kayachikitsa |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
PG Department of Kaychikitsa, Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, Najafgarh, New Delhi
South West
DELHI
110073
India |
| Phone |
8506964826 |
| Fax |
|
| Email |
dr.rajendrasoni@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, Najafgarh, New Delhi, India- 110073 |
|
|
Primary Sponsor
|
| Name |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, Najafgarh, New Delhi, India-110073 |
| 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 Anushka Abhay Singh |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
Room no. 108, PG Department of Kayachikitsa, Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, Najafgarh, New Delhi
South West
DELHI |
8377095512
anushkasingh9september@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee,Chaudhary Brahm Prakash Ayurved Charak Sansthan |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Dhatri Lauha, Reference: Bhaisajya Ratnavali Shoolaroga chikitsa Chapter number 30 Shloka number 149 to 154, Route: Oral, Dosage Form: Lauha-Mandura, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ashtadashang Lauha, Reference: Bhavaprakasha Madhyama khanda Pandukamalahalimaka adhikara Chapter number 8 Shloka number 34 to 36, Route: Oral, Dosage Form: Lauha-Mandura, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients between the age group 21 and 60 years,
irrespective of gender, caste and
religion
2. Patient not suffering from any severe disease
other than Iron deficiency Anaemia.
3.Haemoglobin level between 6 to 10.9 gm/dl
4. Patients with S.ferritin level below 24 ng/ml
5.Patient willing to sign the informed consent for
study.
6. Patient who are able to take medicine orally.
7. Patient who are not registered in any other
research projects. |
|
| ExclusionCriteria |
| Details |
1. Patients suffering from any other systemic
diseases like Renal disorders, Heart
disease, Cancer, Haemophilia, Acquired immune
deficiency syndrome etc.
2.Age less than 21 years and more than 60 years
3. Haemoglobin level below 6 gm/dl and more than
10.9 gm/dl
4. Pregnant women and lactating mothers
5. Patients suffering from Krimijanya Pandu roga
6. Patient not willing to sign the informed
consent
7. Patient who are not able to take medicine
orally
8. Patient registered in any other research
projects
9. Patient already taking any medicine for Anaemia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in S. Ferritin Level |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in Following Clinical Features:
A. Haemoglobin
B. Panduta
C. Shwasa
D. Bhrama
E. Gauravata
F. Aruchi
G. Saad
H. Nidralu |
60 days |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
03/02/2025 |
| 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="6"
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
|
Pandu is a rasa pradoshaj vikar, it is due to excessive exacerbations of three doshas especially pitta afflicts dhatus as a result complexion, strength, unctuousness and other property also get too much diminished due to morbidity of dosha and dushya and then blood, fat and ojas get exceedingly reduced leading to development of Pandu roga. Symptoms of Pandu roga include Panduta, shwasa, bhrama, gauravata, aruchi, saad and nidralu. Pandu is a symptom as well as a disease and mostly resembles with Anaemia of modern science. Anaemia is a condition in which the number of red blood cells or the haemoglobin concentration within them is lower than normal. Haemoglobin is needed to carry oxygen and if you have too few or abnormal red blood cells, or not enough Haemoglobin, there will be a decreased capacity of the blood to carry oxygen to the body tissues. This results in symptoms such as fatigue, weakness, dizziness and shortness of breath. Iron deficiency anaemia is the most common form of anaemia in the world, including India. It arises when the balance of iron intake, iron stores, and the bodys loss of iron are insufficient to fully support the production of erythrocytes. It is a health problem that affects major portions of the population in underdeveloped countries. The Global Burden of Diseases, Injuries, and Risk Factors study 2013 reported that iron deficiency is the most significant contributor to the onset of anaemia. As per the WHO report 2001, there are about two billion anaemia cases globally, of which half is iron-deficiency anaemia IDA affecting 30 percent of the population worldwide. The present study aims to evaluate the comparative effect of Ashtadashang Lauha and Dhatri Lauha in the improvement of S. ferritin levels and haemoglobin levels, along with reduction in the symptoms of Pandu roga. The total number of patients is 62, 31 in each group. In Group A, Ashtadashang Lauha will be administered in a dose of 500 mg twice daily one hour after meals with Madhu. In Group B, Dhatri Lauha will be administered in a dose of 500 mg twice daily one hour after meals with Madhu. The design of the study is a single-centered, open label, randomized, comparative and interventional study. |