| CTRI Number |
CTRI/2024/11/076415 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
10/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Treatment of Sickle cell Anemia by Herbal medicines |
|
Scientific Title of Study
|
A Clinico-Pathological study of Sickle Cell Anemia WSR to Sannipatika Pandu and Management by Poly Herbal Formulation with Standard Care |
| Trial Acronym |
MANAGEMENT OF SCA WITH PHF WITH STANDARD CARE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Harish Chandra Giri |
| Designation |
Assistant professor |
| Affiliation |
Sri Sri College of ayurvedic science and research hospital |
| Address |
Room no D -212 , Kirti buildingSri Sri College of Ayurvedic Science and Reserch Hospital,Sri Sri University, Godisahi,Bidyadharpur, Cuttack
Cuttack
ORISSA
754006
India |
| Phone |
6370925058 |
| Fax |
|
| Email |
harishgirimdnidana68@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof.(Dr.) Pradip kumar Panda |
| Designation |
Dean ,Professor and HOD |
| Affiliation |
Sri Sri College of ayurvedic science and research hospital |
| Address |
Sri Sri College of Ayurvedic Science and Reserch Hospital,Sri Sri University, Godisahi,Bidyadharpur, Cuttack
ORISSA
754006
India |
| Phone |
9777868699 |
| Fax |
|
| Email |
deansscasrh@srisriuniversity.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harish Chandra Giri |
| Designation |
Assistant professor |
| Affiliation |
Sri Sri College of ayurvedic science and research hospital |
| Address |
Room no D-212 ,Kirtibuilding Sri Sri College of Ayurvedic Science and Reserch Hospital,Sri Sri University, Godisahi,Bidyadharpur, Cuttack
ORISSA
754006
India |
| Phone |
6370925058 |
| Fax |
|
| Email |
harishgirimdnidana68@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self funder
Study will be at Sri Sri College of Ayurvedic Science and reserch hospital ,Sri Sri University,Godisahi,Cuttack ,Odisha ,PIN 754006 |
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
DEPARTMENT OF ROGA NIDAN ,SSCASRH ,SSU,GODISAHI,BIDYADHARPUR,CUTTACK,ODISHA |
| Type of Sponsor |
Other [Self] |
|
|
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 Harish Chandra Giri |
Sri Sri College of Ayurvedic science and research hospital |
room no D 120 kirti building Sri Sri College of Ayurvedic Science and Reserch Hospital,Sri Sri University, Godisahi,Bidyadharpur, Cuttack
Cuttack
ORISSA |
06370925058
harishgirimdnidana68@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical comittesri sri college of ayurvedic science and reaearch hoapita, |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D570||Hb-SS disease with crisis. Ayurveda Condition: PANDUROGAH, (2) ICD-10 Condition:D570||Hb-SS disease with crisis. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: POLY HERBAL FORMULATION, Reference: Dravyaguna vigyan by Priyavat Sharma, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -JALA), Additional Information: -No classical reference for polyherbal formulation | | 2 | Comparator Arm (Non Ayurveda) | | - | Hydroxyurea | Name: Hydroxyurea
Dose: 10-15 mg/kg
Frequency: once daily orally
|
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Having Clinical Sign and Symptoms of SCD. (as per VAS score) and Vaso-occlusive events 1-10 in past 12 months |
|
| ExclusionCriteria |
| Details |
Heterozygous sickle cell disease(HbAS) |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Poly herbal formulation(Trial drug) is effective in treating Sickle Cell Anaemia Stabilisation. |
One year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Poly herbal formulation is more effective than Hydroxyurea(Control drug) for Prophylactic management of Sickle Cell Anaemia . |
Poly herbal formulation is more effective than Hydroxyurea(Control drug) for Prophylactic management of Sickle Cell Anaemia . |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/12/2024 |
| 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="0"
Months="11"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| 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
Modification(s)
|
The clinical trial on the management of Sickle Cell Anaemia by Poly herbal formulation with standard care of Hydroxyurea has been started from 7th November 2025 and till date 32 participants have registered in this clinical trial.
|