| CTRI Number |
CTRI/2023/02/049593 [Registered on: 09/02/2023] Trial Registered Prospectively |
| Last Modified On: |
26/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Dashmool Visva decoction and punarnava Mandoor in Kaphaj Pandu (Anaemia) |
|
Scientific Title of Study
|
Randomized controlled study to compare the efficacy of Dashmool Visva decoction with Punarnava Mandoor in improving Haemoglobin level in Kaphaj Pandu (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 Bhawana Agarwal |
| Designation |
MD Scholar |
| Affiliation |
Ch Brham Prakash Ayurved Charak Sansthan |
| Address |
Department of Kayachikitsa Ch Brham Prakash Ayurved Charak Sansthan khera dabar New Delhi
South West
DELHI
110073
India |
| Phone |
8209048971 |
| Fax |
|
| Email |
bhawanaagarwal95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr N R singh |
| Designation |
Head of Department |
| Affiliation |
Ch Brham Prakash Ayurved Charak Sansthan |
| Address |
Department of Kayachikitsa Ch Brham Prakash Ayurved Charak Sansthan khera dabar New Delhi
South West
DELHI
110073
India |
| Phone |
9560659728 |
| Fax |
|
| Email |
naimishraj@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhawana Agarwal |
| Designation |
MD Scholar |
| Affiliation |
Ch Brham Prakash Ayurved Charak Sansthan |
| Address |
Department of Kayachikitsa Ch Brham Prakash Ayurved Charak Sansthan khera dabar New Delhi
South West
DELHI
110073
India |
| Phone |
8209048971 |
| Fax |
|
| Email |
bhawanaagarwal95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ch Brham Prakash Ayurved Charak sansthan Khera Dabar New Delhi |
|
|
Primary Sponsor
|
| Name |
Ch Brham Prakash Ayurved Charak Sansthan |
| Address |
Khera Dabar Najafgarh South West Delhi New Delhi 110073 India |
| 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 |
| Bhawana Agarwal |
Ch Brham Prakash Ayurved Charak Sansthan |
Department of Kayachikitsa Ch Brham Prakash Ayurved Charak Sansthan khera dabar New Delhi 110073
South West
DELHI |
8209048971
bhawanaagarwal95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC CBPACS |
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: Punarnava Mandoor, Reference: Charak Chikitsa 16, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: -NIL | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dashmool Visva kwath, Reference: Yog Ratnakar, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: -NIL |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients not suffering from any severe disease other than Iron deficiency Anaemia.
2. Haemoglobin level -between 6-11 gm/dl.
3. Patients who can take medicines orally. |
|
| ExclusionCriteria |
| Details |
1. Patients suffering from any other systemic diseases like Renal disorders, Heart disease, Cancer, acquired immune deficiency syndrome etc.
2. Age <18 years and more than 60 years
3. Haemoglobin level-below 6 gm/dl and more than 11 gm/dl.
4. Pregnant women and lactating mothers.
5. Patients already taking any medicine for Anaemia.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Haemoglobin Level |
Day0
Day15
Day30
Day45
Day60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in Following Clinical Features:
1-Pandutaa (Pallor), 2-Swash (Dyspnoea), 3-Bhrama (Dizziness)
4-Gauravta (Heaviness in body), 5-Aruchi (Anorexia), 6- Saad (fatigue)
7- Nidhralu (Excessive Sleep) |
Day 0, Day 15, Day 30, Day 45, Day 60 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/02/2023 |
| Date of Study Completion (India) |
10/02/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
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. Pandu is a symptom as well as a disease characterized by pallor
discolouration. 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’s tissues. This results in symptoms such as Fatigue, Weakness, Dizziness and
Shortness of breath, among others. The signs include loss of normal colour in the skin and also in the lips, tongue, nail
beds and the blood vessels in the sclera part of the eye. Without treatment, Anaemia can worsen and become underlying causes of chronic ill health, such as impaired
foetal development during pregnancy, delayed cognitive development and increased
risk of infection in young children and reduced physical capacity in all people.
This study is to compare the efficacy of Dashmool Visva decoction and Punarnava Mandoor in the management of kaphaj Pandu (Iron Deficiency Anaemia). Total no. of patient is 50, 25 in each group. In group A Punarnava Mandoor is given in dose of 2 tablets (250mg each) twice a day after 1 hour of meal with lukewarm water for 45 days. In group B Dashmool Visva kwath is given in dose of 40 ml twice a day after 1 hour of meal with lukewarm water for 45 days. Study design is single centered, open label, randomized, interventional type, comparative study. |