| CTRI Number |
CTRI/2024/07/070414 [Registered on: 10/07/2024] Trial Registered Prospectively |
| Last Modified On: |
09/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Compare the Effect of Gaumutra Bhavit Mandoor Bhasma and Dhatri Lauh in the management of Pandu(Anemia) in pre-school children |
|
Scientific Title of Study
|
A Randomized Open Labelled Comparative Controlled Clinical Study to evaluate the efficacy of Gaumutra Bhavit Mandoor Bhasma and Dhatri Lauh in the management of Pandu Moderate Iron Deficiency Anemia in pre school children |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amman Samota |
| Designation |
PG Scholar |
| Affiliation |
Institute for Ayurved Studies and Research former Shri Krishna Government Ayurvedic College |
| Address |
Department of Kaumarbhritya Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra 136118 Haryana India
Kurukshetra
HARYANA
136118
India |
| Phone |
8708062076 |
| Fax |
|
| Email |
amman170997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Kataria |
| Designation |
Associate Professor PG Department of Kaumarbhritya |
| Affiliation |
Institute for Ayurved Studies and Research former Shri Krishna Government Ayurvedic College |
| Address |
Department of Kaumarbhritya Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra 136118 Haryana India
Kurukshetra
HARYANA
136118
India |
| Phone |
9034001230 |
| Fax |
|
| Email |
dramitkataria@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amman Samota |
| Designation |
PG Scholar |
| Affiliation |
Institute for Ayurved Studies and Research Former Shri Krishna Government Ayurvedic College |
| Address |
Department of Kaumarbhritya Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra 136118 Haryana India
Kurukshetra
HARYANA
136118
India |
| Phone |
8708062076 |
| Fax |
|
| Email |
amman170997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Ayurved Studies and Research former Shri Krishna Government Ayurvedic College and Hospital Shri Krishna AYUSH University Umri Road Sector 8 Kurukshetra 136118 Haryana India |
|
|
Primary Sponsor
|
| Name |
Institute for Ayurved Studies and Research |
| Address |
Institute for Ayurved Studies and Research Former Shri Krishna Governmengt Ayurvedic College and Hospital Shri Krishna AYUSH University Umri Road Sector 8 Kurukshetra 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 Amman Samota |
Institute for Ayurved Studies and Research |
Kaumarbhritya OPD Room No 53 Institute for Ayurved Studies and Research Former Shri Krishna Government Ayurvedic College and Hospital Umri Road Sector 8 Kurukshetra 136118
Kurukshetra
HARYANA |
8708062076
amman170997@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: Gaumutra Bhavit Mandoor Bhasma, Reference: Vangasena Samhita Pandu Roga verse 26, Route: Oral, Dosage Form: Bhasma, Dose: 116(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Guda (Jaggery)), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Dhatri Lauh, Reference: Bhaishajya Ratnawli Chapter-30 Verse 149-154, Route: Oral, Dosage Form: Bhasma, Dose: 160(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Guda (Jaggery)), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Patient will be included in trial after deworming.
Patient of either sex, caste, religion and aged between of 3-5 years (Pre-school children).
The patients having Hb in between 7.0-9.9 gm% (as per WHO classification of Moderate Anemia).
The patients with sign and symptoms of Pandu (Moderate Iron deficiency anemia). |
|
| ExclusionCriteria |
| Details |
Patient having age less than 3 years and above 5 years.
Patient having Hb levels below 7.0gm% or above 9.9gm %.
Children already diagnosed / Newly diagnosed case of the Tuberculosis, Bleeding Disorders, Sickle cell anemia, Thalassemia, Diaarhoea, Leukemia and the major systemic illness. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| All the signs and symptoms of Pandu(moderate iron deficiency anemia) will be assigned score depending upon their severity to assess the effect of drug at the time of before treatment and after treatment |
30 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effect of Pathya Apathya Counselling in the management of Pandu(moderate iron deficiency anemia) |
30 days |
|
|
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 |
|
Date of First Enrollment (India)
|
22/07/2024 |
| 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) |
Open to Recruitment |
|
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
|
Ayurveda has described Pandu as a disease characterized by change of the normal color of the body to different degree of paleness (dull red, pale yellow and white in successive stages) and the Rakta is the chief Dushya. The literal meaning of Pandu word is Ketkidhuli Sannibha which means patients skin resembles with pollen grain of Ketki Pushpa. It is a Rasa Pradoshaja Vyadhi. According to Ayurveda prominent diagnostic feature of Pandu is the pallor on the skin which occurs due to quantitative & qualitative deficiency of Raktdhatu and Rasdhatu. Rakta has been considered as a key factor for the Jeevan (life), Prinana (provides nutrition to other dhatus) Karma of the body. It is seen that Rakta gets vitiated by Doshas, mainly by Pitta Dosha as Rakta is Pittavargiya and the diseases like Pandu appears. Pitta aggravating diet and behaviour are the etiological factors for this disease. Considering Panduta is predominant sign the disease is term as Pandu.In modern days we can correlate Pandu as Anemia on the basis of similarities of clinical features.According to W.H.O. (World Health Organization) the incidence rate of Iron-deficiency Anemia among under five children is 39.8% in 2019.. In view of the increasing prevalence ratio the study has been undertaken to analyze each and every aspect related to Pandu (Iron deficiency Anemia) and proper management protocol. Ayurvedic management is very helpful to improve the life of children suffering from Pandu (Iron deficiency Anemia).So, for easy palatability this Ayurvedic medicine should be considered. |