| CTRI Number |
CTRI/2025/12/099438 [Registered on: 18/12/2025] Trial Registered Prospectively |
| Last Modified On: |
30/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
effect of Ayurvedic medicine in pain crisis management in the students with sickle cell disease |
|
Scientific Title of Study
|
A randomized clinical trial to evaluate the effect of Ayush RP as an adjuvant in prevention of acute pain crises in sickle cell Disease in students of selected Ekalavya Model Residential Schools |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prashant Shinde |
| Designation |
Research officer |
| Affiliation |
central council for Research in Ayurvedic Sciences, New Delhi |
| Address |
Jawaharlal Neharu Bharatiya Chikitsa evam Homeopathy Anusandhan Bhawan
61-65 institutional area
opposite to block D
Janakpuri
61-65 opposite to D Block, Institutional Area
New Delhi
DELHI
110058
India |
| Phone |
9623011214 |
| Fax |
|
| Email |
drshindeprashant07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Renu Singh |
| Designation |
Research officer |
| Affiliation |
central council for Research in Ayurvedic Sciences, New Delhi |
| Address |
Jawaharlal Neharu Bharatiya Chikitsa evam Homeopathy Anusandhan Bhawan
61-65 institutional area
opposite to block D
Janakpuri
61-65 opposite to D Block, Institutional Area
New Delhi
DELHI
110058
India |
| Phone |
8826570500 |
| Fax |
|
| Email |
drrenusingh@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Renu Singh |
| Designation |
Research officer |
| Affiliation |
central council for Research in Ayurvedic Sciences, New Delhi |
| Address |
Jawaharlal Neharu Bharatiya Chikitsa evam Homeopathy Anusandhan Bhawan
61-65 institutional area
opposite to block D
Janakpuri
61-65 opposite to D Block, Institutional Area
DELHI
110058
India |
| Phone |
8826570500 |
| Fax |
|
| Email |
drrenusingh@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Ayurvedic Sciences
Jawaharlal Neharu Bharatiya Chikitsa evam Anusandhan Bhawan, 61-65 Insituttional Area Janakpuri 110058 Delhi |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Ayurvedic Sciences |
| Address |
Jawaharlal Neharu Bharatiya Chikitsa Avam Homeopathy Anusandhan Bhawan
61-65 institutional area
Janakpuri 110058 Delhi |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 11 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Savita Sharma |
RARi, Gwalior |
Aamkho, Gwalior-474009 (M.P.)
Gwalior
MADHYA PRADESH |
8149526366
savitashirish@yahoo.co.in |
| Dr K Pramila Devi |
ALRARI, Chennai |
Pallipattu, Tharamani Chennai
Chennai
TAMIL NADU |
9445812604
kprameel@gmail.com |
| Dr Purnendu Panda |
CARI, Bhubaneswar |
Bharatpur Bhubaneswar 751029
Khordha
ORISSA |
9777852889
pandapurnendu02@gmail.com |
| Dr Shree Lakshmi RS |
RARI Gangtok |
TADONG, GANTOK, SIKKIM -737102
East
SIKKIM |
9207501869
sreelakshmirs069@gmail.com |
| Dr savita Gopad |
RARI Vijaywada |
New Rajiv Nagar, Payakapuram, Vijayawada, Andhrapradhesh 520015
Krishna
ANDHRA PRADESH |
9177777631
savitagopod18@gmail.com |
| Dr Parth Dave |
RARI, Ahmedabad |
Bahumali Bhavan, Manjushree Mill Compound,
Nr. Girdharnagar Overbridge, Asarwa, AHMEDABAD - 380 004
Ahmadabad
GUJARAT |
9638948973
drppdave88@gmail.com |
| Dr Poonam Mohod |
RARI, Jammu |
Rajendra nagar, Banataalab Jammu
Jammu
JAMMU & KASHMIR |
8511437041
poonarnawa10@gmail.com |
| Dr Anjali Prasad |
RARI, Lucknow |
INS 106sector 25 Indira Nagar Lucknow 226016
Lucknow
UTTAR PRADESH |
7737498848
anjali.prasad75@gmail.com |
| Dr Kuldeep Choudhary |
RARI, Mumbai |
Podar Medical Campus, Dr. Annie Besant Road, Worli, Mumbai-400018, Maharashtra, India
Mumbai
MAHARASHTRA |
8198865710
drkuldeepall@gmail.com |
| Dr Manisha Talekar |
RARI, Nagpur |
NIT complex Gokul Niwas Nandanwan District Nagpur State maharashtra
Nagpur
MAHARASHTRA |
8999107282
dr.mani21jan@gmail.com |
| Dr Tarun Kumar |
RARI, Ranikhet |
Ranikhet (Thapala), PO Ganiyadholi
Almora
UTTARANCHAL |
9990167451
dr.tarunbams3887@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 11 |
| Name of Committee |
Approval Status |
| ALRARI, Chennai |
Approved |
| CARI, Bhubaneswar |
Submittted/Under Review |
| CARI, Mumbai |
Submittted/Under Review |
| RARI, Ahmedabad |
Approved |
| RARI, Gangtok |
Approved |
| RARI, Gwalior |
Approved |
| RARI, Jammu |
Approved |
| RARI, Lucknow |
Approved |
| RARI, Nagpur |
Submittted/Under Review |
| RARI, Ranikhet |
Approved |
| RARI, Vijaywada |
Submittted/Under Review |
|
|
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, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Ayush RP, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 8 Months, anupAna/sahapAna: Yes(details: lukewarm water), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | conventional Therapy | 1. Hydroxyurea
2. Folic acid
as per guidlines |
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1.Students studying in the EMR School of age 10-18 years
2.Diagnosed with Sickle cell disease
3.Parents/guardians willing to provide a written informed consent for the participation of their child.
4.Student willing to provide Assent for the participation
5.Students who had no intention of leaving the schools until the end of the study will be included in this study.
|
|
| ExclusionCriteria |
| Details |
1.Students suffering from uncontrolled intercurrent illness or any serious infection or illness
2.student on hyper transfusion therapy
3.Previously undergone hematopoietic stem cell transplant or solid organ transplant
4. Known cases of underlying chronic diseases (cardiac, renal, tuberculosis, liver disease), neurological or hereditary disease.
5.Students with congenital abnormalities needing medical/surgical intervention
6.Refuse to take the medicine
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Frequency of sickle cell-related pain crises during the study period |
Baseline and 8th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| i.severity of painful crisis (on the basis of Visual analogue score (VAS) |
Baseline and 8th month |
Change in the Hemoglobin level
|
Baseline and 8th Month |
| Change in the health-related quality of life (assessed through Short Form-12 questionnaire) |
Baseline and 8th month |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/12/2025 |
| 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="0"
Months="8"
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
|
1. The clinical course of patients with sickle cell disease (SCD) is highly variable due to the interplay of many genetic and environmental factors. Although hydroxyurea (HU) reduces morbidity and mortality in adults and pediatric patients with SCD, nearly one third of patients do not respond. Therefore, there is a need to evaluate the role of alternative medicine for the effective management of disease. |