| CTRI Number |
CTRI/2024/05/068195 [Registered on: 31/05/2024] Trial Registered Prospectively |
| Last Modified On: |
30/05/2024 |
| 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
|
Management of anemia (Pandu) in children (6-13 yrs) with vidangadiloham vati. |
|
Scientific Title of Study
|
A Randomized Open Labeled Controlled Clinical Trial To Evaluate The Efficacy Of Darvyadiloham In Pandu With Special Reference To Iron Deficiency Anemia In Children (6-13 years) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jayakumar Prakash Patil |
| Designation |
PhD scholar |
| Affiliation |
PDEAs College of Ayurved and Research Centre, Nigdi, Pune |
| Address |
Sector number 25, Pradhikaran, Nigdi, Pune 44.
Plot number 36, Shambhu Mahadev Nagar, Goleshwar, Tal Karad Dist Satara Pincode 415124
Pune
MAHARASHTRA
411044
India |
| Phone |
9175650898 |
| Fax |
|
| Email |
drjaypatil22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Madhavi S Deodas |
| Designation |
Professor and Head of Dept. of Kaumarbhritya |
| Affiliation |
PDEAs College of Ayurved and Research Centre, Nigdi, Pune |
| Address |
Sector number 25, Pradhikaran, Nigdi, Pune 44.
Pune
MAHARASHTRA
411044
India |
| Phone |
9423010818 |
| Fax |
|
| Email |
drdeodasms@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Madhavi S Deodas |
| Designation |
Professor and Head of Dept. of Kaumarbhritya |
| Affiliation |
PDEAs College of Ayurved and Research Centre, Nigdi, Pune |
| Address |
Sector number 25, Pradhikaran, Nigdi, Pune 44.
Pune
MAHARASHTRA
411044
India |
| Phone |
9423010818 |
| Fax |
|
| Email |
drdeodasms@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research Centre Sector number 25 Pradhikaran Nigdi Pune 44 |
|
|
Primary Sponsor
|
| Name |
PDEAs College of Ayurved and Research Centre |
| Address |
Sector number 25 Pradhikaran Nigdi Pune 44. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jayakumar Patil |
Jaywant Ayurvedic Hospital and Research Center, Kille Machindragad, Tal Walwa |
Kaumarbhritya OPD, Ground Floor
Sangli
MAHARASHTRA |
9175650898
drjaypatil22@gmail.com |
| Dr Jayakumar Patil |
PDEAS Ayurved Rugnalaya and Sterling Multispecialty Hospital, Nigdi, Pune |
Balroga Department, Ground Floor, OPD No. 118
Pune
MAHARASHTRA |
9175650898
drjaypatil22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee PDEAS College of Ayurved and Reasearch Center, Nigdi. |
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: Vidangadiloham, Reference: Rasendra Sar Sangraha Pandu Kamala Chikitsa Adhyaya Page number 255, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 125(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 56 Days, anupAna/sahapAna: Yes(details: -Puratana Guda (Jaggery)), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Darvyadiloham, Reference: Rasendra Sar Sangraha Pandu Kamala Chikitsa Adhyaya Page number 256, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 125(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 56 Days, anupAna/sahapAna: Yes(details: Madhu and Ghrita-), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients with iron deficiency anemia (Hb 8gm%-11gm%)
2)Patients with classical sign and symptoms described in Charak Samhita Adhyaya 16.
3)Patients whose parents are willing to give consent for clinical trial. |
|
| ExclusionCriteria |
| Details |
1)Patients suffering from systemic illness necessitating long term treatment.
2)Patients with other causes of anemia like thalassemia, sickle cell anemia, aplastic anemia, hemolytic anemia, anemia due to blood loss.
3)Patients with k/c/o malignancy.
4)History of hypersensitivity to any of the trial drug or their ingredients.
5)Patients who have completed participation in any other clinical trial during the past six months. |
|
|
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 |
| To evaluate the clinical efficacy of Darvyadiloham in increasing hemoglobin percentage in the management of Pandu in children. |
Assessment after 56 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the symptomatic relief in clinical signs of Pandu namely Panduta, Hritspandan, Akshikutshotha, Daurbalya, Shrama etc.
To assess the change in hemoglobin & peripheral blood smear. |
Clinical assessment on 7th, 14th, 28th, 42nd day.
Laboratory evaluation on 56th day.
|
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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 |
|
Date of First Enrollment (India)
|
15/06/2024 |
| 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="3"
Months="0"
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
|
Anemia is a condition in which the number of red blood cells and consequently their oxygen carrying capacity is insufficient to meet body’s physiological needs. India is one of the countries with very high prevalence of anemia in the world. The NFHS 3 data suggesting that anemia is widely prevalent among all age groups with overall prevalence of 50% in school aged children. Anemia has been described many years ago by the name of Panduroga in Ayurveda. Ayurveda documents large number of preparations for management of Pandu of which Darvyadiloham from Rasendrasarsangraha is selected for present study. |