| CTRI Number |
CTRI/2024/07/071147 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
19/07/2024 |
| 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 Comparative Clinical Study to Evaluate the Efficacy of Gudanagaradi Gutika and Phalatrikadi Kwatha in the Management of Pandu Roga (Iron Deficiency Anaemia) |
|
Scientific Title of Study
|
An Open Labelled Parallel Comparative Clinical Study to evaluate the efficacy of Gudanagaradi Gutika
and Phalatrikadi Kwatha in the Management of Pandu Roga with Special Reference 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 |
Dr Pooja |
| Designation |
PG scholar |
| Affiliation |
Institute For Ayurved Studies and Research |
| Address |
Room no. 79,Department of Kayachikitsa,Institute for Ayurved Studies and Research,SKAU,Sector 8, Umri road, Kurukshetra, Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
7814522588 |
| Fax |
|
| Email |
poojak0023@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Neelam Kumari |
| Designation |
Professor and Chairperson |
| Affiliation |
Institute For Ayurved Studies and Research |
| Address |
Room no.56,Department of Kayachikitsa, Institute for Ayurved Studies and Research, SKAU, Sector 8, Umri road, Kurukshetra, Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
9671368058 |
| Fax |
|
| Email |
mehranilam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja |
| Designation |
PG scholar |
| Affiliation |
Institute For Ayurved Studies and Research |
| Address |
Room no. 79,Department of Kayachikitsa,Institute for Ayurved Studies and Research,SKAU,Sector 8, Umri road, Kurukshetra, Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
7814522588 |
| Fax |
|
| Email |
poojak0023@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Ayurved studies and research |
|
|
Primary Sponsor
|
| Name |
Institute For Ayurved Studies and Research |
| Address |
Sector 8, Umri Road, Kurukshetra, Haryana, 136118 |
| 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 |
| Dr Pooja |
Institute For Ayurved Studies and Research |
Room no. 79,Department of Kayachikitsa,Institute for Ayurved Studies and Research,SKAU
Kurukshetra
HARYANA |
7814522588
poojak0023@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SHRI KRISHNA AYUSH UNIVERSITY |
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: Gudanagaradi gutika, Reference: Charak samhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Phalatrikadi kwatha, Reference: Bhaisajya ratnavali, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient willing to sign the consent form.
2. All patients of age group (25-45years) irrespective of any sex, community and locality
will be included.
3. Patients fulfilling the diagnostic criteria for Pandu Roga.
4. Iron Deficiency Anemia (IDA) of mild and moderate types (Hb% within the range of 8-
11gm/dl) will be included.
|
|
| ExclusionCriteria |
| Details |
1. Patient not willing for clinical trials
2. Patient below age 25 and above age 45 years.
3. Anemia other than IDA will be excluded.
4. Patients of acute blood loss will be excluded.
5. Anemia due to Leukemia & other malignant disorders will be excluded.
6. Hb% below range of 8gm/dl.
7. Patients with history of other systemic diseases such as Diabetes mellitus, CAD,
CKD,AKD and endocrinal disorder.
8. Pregnant and lactating women.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of Gudanagaradi gutika in comparison to Phaltrikadi kwath by applying appropriate statistical tools in the management of pandu roga with special reference to iron deficiency anemia |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Increase in Hb%
2. Improvement in sign and symptoms of disease
3. Improvement in other biological parameters, general health conditions and quality of life |
56 day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
05/08/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 Roga(Anaemia)
is one of the commonest disease affecting all age group. According to Acharya
Charaka, Pandu Roga(Anaemia) is a Rasapradoshaja Vyadhi in
which Vivarnata of Twaka is mainly Pandu due to Raktalpata
and with symptoms of Agnimandya, Aruchi, shrama, shwasa etc.Pandu
Roga (Anamemia) is highly prevelent in today’s era.Iron Deficiency Anaemia
is defined as an insufficient RBC may be due to increased RBC clearance,
decreased RBC production, or both .So a study will be conducted with the aim to
evaluate the efficacy of Gudanagaradi Gutika in comparison to Phalatrikadi
Kwatha in the management of Pandu Roga for which 60 patients will be
randomly selected and divided into 2 groups. In groups A (30 patients) Gudanagaradi
Gutika 500 mg will be given twice after meal with lukewarm water and in
group B (30 patients) Phalatrikadi Kwatha 50 ml will be given
twice after meal with equal amount of water for 28 days. Patients will be
regularly followed up at an interval of 7 days during treatment and 2 follow-ups will be scheduled at interval of 14 days after treatment. Clinical features
and laboratory investigations will be analysed during and after treatment.
Results will be analysed in accordance with the appropriate statistical tests. |