| CTRI Number |
CTRI/2025/04/084042 [Registered on: 03/04/2025] Trial Registered Prospectively |
| Last Modified On: |
26/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of Herbo-Mineral Compound and Standard care on Sickle cell Anaemia |
|
Scientific Title of Study
|
A CLINICO-PATHOLOGICAL STUDY OF HERBO-MINERAL COMPOUND WITH STANDARD CARE ON SICKLE CELL ANEMIA
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dusmanta Kumar Majhi |
| Designation |
Lecturer PG Department of Roga Nidana GAC and H Balangir |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital Sri Sri University Cuttack |
| Address |
Sri Sri University Cuttack
Ward No 3
Sandhapu
Godi sahi
Odisha
754006
Sri Sri University Cuttack
Ward No 3
Sandhapu
Godi sahi
Odisha
754006
Cuttack
ORISSA
754006
India |
| Phone |
09668289599 |
| Fax |
|
| Email |
dusmanta.m2022-23ds@srisriuniversity.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Pradip Kumar Panda |
| Designation |
Dean, SSCASRH Sri Sri University Cuttack |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital Sri Sri University Cuttack |
| Address |
Sri Sri University Cuttack
Ward No 3
Sandhapu
Godi sahi
Odisha
754006
Sri Sri University Cuttack
Ward No 3
Sandhapu
Godi sahi
Odisha
754006
Cuttack
ORISSA
754006
India |
| Phone |
9777868699 |
| Fax |
|
| Email |
profpkpanda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Pradip Kumar Panda |
| Designation |
Dean, SSCASRH Sri Sri University Cuttack |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital Sri Sri University Cuttack |
| Address |
Sri Sri University Cuttack
Ward No 3
Sandhapu
Godi sahi
Odisha
754006
Sri Sri University Cuttack
Ward No 3
Sandhapu
Godi sahi
Odisha
754006
Cuttack
ORISSA
754006
India |
| Phone |
9777868699 |
| Fax |
|
| Email |
profpkpanda@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dusmanta Kumar Majhi,
Lecturer, PG Department of Roga Nidana, GAC and H, Balangir |
|
|
Primary Sponsor
|
| Name |
Dusmanta Kumar Majhi |
| Address |
Sri Sri University Cuttack
Ward No 3
Sandhapu
Godi sahi
Odisha
754006 |
| 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 |
| Prof Dr Pradip Kumar Panda |
Sri Sri University, Cuttack |
OPD and IPD Sri Sri University, Cuttack
Cuttack
ORISSA |
9777868699
profpkpanda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Biomedical Research of Faculty of Health & Wellness, Sri Sri College of Ayurvedic Science and Research Hospital, Sri Sri University Cuttack |
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: RASAVAHASROTOVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Herbo-Mineral Compound, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Ushna Jala), Additional Information: -Herbo-Mineral Compound Constituents:-
1-Guduchi Satwa
2-Amalaki
3-Aswagandha
4-Maricha
5-Pravala Pistee
6-Muktasukti Pistee
7-Sankha Bhasma
8- Roupya Bhasma | | 2 | Comparator Arm (Non Ayurveda) | | - | Hydroxyurea | Route: Oral
Dosage Form: Tablet
Dose: 10-15mg/kg
Frequency: Od
Bhaisajya Kal: After Food
Duaration: 90 days |
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.12 years of age up to 50 years, Both sexes
2. Homozygous sickle cell disease (HbSS)
3. Having Clinical Sign and Symptoms of SCD.
4. Vaso-occlusive events 1-10 in past 12 months
5. Willing to adhere to study procedures and to give written informed consent
|
|
| ExclusionCriteria |
| Details |
1. Age less than 12 years and more than 50 years
2. Heterozygous sickle cell disease (HbAS)
3. Chronic illness and pain disorders (leg ulcers, fever, fractures causing pain)
4. Pregnant, lactating mother, planning pregnancy,
5. Transfusion within 3 weeks and any other Grievous causes.
6. Refusal to provide access to relevant medical records/Consent
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in Symptoms like Panduta, Durvalata, Sadana, Angamarda, Jwara, Swasa, Aruchi, Gourava, Chhardi, Mala-mutra & Netraswetata |
Decrease in Symptoms like Panduta, Durvalata, Sadana, Angamarda, Jwara, Swasa, Aruchi, Gourava, Chhardi, Mala-mutra & Netraswetata |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Herbo-Mineral Compound is more effective than Hydroxyurea |
91 Days |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
06/04/2025 |
| 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)
|
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
|
This is a Clinco-Pathological study of Herbo-Mineral Compound with Standard Care on Sickle cell Anemia. This is done Compulsory part of Ph.D Course. Total Number of patients to be studied is 70 with duration of 90 Days. |