| CTRI Number |
CTRI/2024/10/076068 [Registered on: 29/10/2024] Trial Registered Prospectively |
| Last Modified On: |
08/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
a study of Agnimantha both species to find efficacy in increasing blood hemoglobin level. |
|
Scientific Title of Study
|
A COMPARATIVE PHARMACO-CLINICAL STUDY OF AGNIMANTHA (PREMNA INTEGRIFOLIA LINN & CLERODENDRUM PHLOMIDIS LINN.) IN PANDU ROGA W.S.R. TO IRON DEFICIENCY ANEMIA. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrTej singh Jatav |
| Designation |
MD Scholar |
| Affiliation |
Pt.Khusi Lal Sharma Government Autonomous Ayurveda College and Institute |
| Address |
Room no 226 Department of Dravyaguna Pt.Khusi Lal Sharma Government Autonomous Ayurveda College and Institute Science Hills behind MANIT Bhopal Madya Pradesh
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9893186235 |
| Fax |
|
| Email |
dr.tsjohari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinod Sharma |
| Designation |
Reader Dravyaguna |
| Affiliation |
Pt.Khusi Lal Sharma Government Autonomous Ayurveda College and Institute |
| Address |
Room no 226 Department of Dravyaguna Pt.Khusi Lal Sharma Government Autonomous Ayurveda College and Institute Science Hills behind MANIT Bhopal Madya Pradesh
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9926379195 |
| Fax |
|
| Email |
sharmavinod389@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrTej singh Jatav |
| Designation |
MD Scholar |
| Affiliation |
Pt.Khusi Lal Sharma Government Autonomous Ayurveda College and Institute |
| Address |
Room no 226 Department of Dravyaguna Pt.Khusi Lal Sharma Government Autonomous Ayurveda College and Institute Science Hills behind MANIT Bhopal Madya Pradesh
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9893186235 |
| Fax |
|
| Email |
dr.tsjohari@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt. Khusi Lal Sharma Government Ayurveda College and Institute Science Hills behind MANIT Bhopal Madhya Pradesh Pincode 462003 |
|
|
Primary Sponsor
|
| Name |
Pt. Khusi Lal Sharma Government Ayurveda College and Institute |
| Address |
Pt. Khusi Lal Sharma Government Ayurveda College and Institute Science Hills behond MANIT Bhopal Madhya Pradesh |
| Type of Sponsor |
Other [State Government Ayurvedic College and institute] |
|
|
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 |
| DrTej Singh Jatav |
Pt Khusi Lal Sharma Government (Autonomous)Ayurveda college and institute |
OPD no 1 Department of Kaya Chikitsa
Bhopal
MADHYA PRADESH |
09893186235
dr.tsjohari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee Pt Khusi Lal Sharma Government Ayurved College and Institute Science Hills Bhopal |
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: Laghu Agnimantha Clerodendrum Phlomidis Linn, Reference: Kaidev nighantu Aushadhi varga 27, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Brihat Agnimantha Premna integrifolia linn, Reference: Bhav Prakah Guduchyadi varga 24, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals aged between 15 to 55 years without any discrimination of gender, caste, religion, etc.
2. Patients fulfilling the diagnostic criteria.
3. Individuals having clinical Sign and symptoms of Pandu according to Ayurvedic classics.
4. Individuals who will give written consent for the study.
5. Hb% between 8 gm to 11gm.
|
|
| ExclusionCriteria |
| Details |
1. Individuals having any known systemic disorders like Cardiac disorders, Renal and Hepatic impairment, Diabetes Mellitus, Thyroid disorders, Gynecological diseases, and any type of Cancers.
2. Pregnancy and Lactating mothers.
3. Others type of known anemia like hemolytic, megaloblastic, pernicious, sickle cell and all types of secondary congenital hereditary and genetically acquired anemia will be excluded.
4. Hb level less than 8 gm/dl.
5. Individuals below 15 years and above 55 years.
6. Any continuing blood loss e.g., Hematemesis, Melena, bleeding piles, etc.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Relief in Pandu Roga Subjective parameters
1.Panduta (Pallor of the body)
2.Anna-Aruchi (Loss of appetite)
3.Pindikoudvesthan (Cramp in calf region).
4.Akchikutshotha (Periorbitledema)
5. Dourbalya (Weakness)
6. Ayasena Shwasa (exertional dyspnoea)
7.Hriday Spandana (Palpitation)
|
subjective parameters will be compared after 30-days intervals. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Mean Haemoglobin level and Relief in objective parameters Like CBC, ESR |
objective parameters like CBC and ESR will be compared after 30-day intervals. |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
02/12/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Applicable |
|
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
|
NEED OF STUDY: - Anemia
is a serious worldwide public health problem that particularly affects young
children, mensurating women, adolescent girls, pregnant women, and post-partum
women. Iron deficiency anemia can cause reduced work capacity in adults,
impacting motor and mental development in children and adolescents. There is
some evidence that iron deficiency anemia affects cognition in adolescent girls
and causes fatigue in adult women. Iron deficiency anemia may affect visual and
auditory functioning and is weakly associated with poor cognitive development
in children.
WHO estimates that 40% of
children 6 months years of age, 37%of pregnant women, and 30%of women 15-49
years of age group worldwide are anemic.
The aim of this study is To
evaluate the comparative efficacy of drug Agnimantha’s varieties
(Premna integrifolia & Clerodendrum
phlomidis) in the management of Pandu roga.
open-labeled clinical study will
be carried out by selected patients from OPD of the department of “Kaya
Chikitsha at Pt. Khushi Lal Sharma Govt. (Auto.) Ayurveda College and
Institute Bhopal. this study
will be done on a total of 60 diagnosed patients of Pandu roga (Anemia
especially Iron deficiency anemia) in two drug groups
(A) Brihat Agnimantha (Premna integrifolia
Linn.) and
(B) Laghu Agnimantha
(Clerodendrum phlomidis Linn.f.) ghan vati.
selected patients will be
investigated by objective parameters - Complete Blood
Count (CBC), ESR, And subjective parameters-
1. Panduta
(Pallor of the body)
2. Anna-Aruchi
(Loss of appetite)
3. Pindikoudvesthan
(Cramp in calf region).
4. Akchikutshotha
(Periorbitledema)
5. Dourbalya
(Weakness)
6. Ayasena
Shwasa (exertional dyspnoea)
7. Hriday
Spandana (Palpitation)
The outcome of the study will be
measured with the help of specially designed proforma and modern parameters. |