| CTRI Number |
CTRI/2025/07/090910 [Registered on: 15/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To Study the Effect and Safety of Raktamrut Vati Along with Standard Treatment in People with Hemophilia. |
|
Scientific Title of Study
|
A Prospective, Open-Label, Four-Arm, Parallel-Group Clinical Study to Evaluate the Efficacy and Safety of Raktamrut Vati as an Adjunct Therapy in Patients with Hemophilia. |
| Trial Acronym |
MAULI 2025 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1324-9336 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shubham Ramnarayan Dhoot |
| Designation |
Principal Investigator |
| Affiliation |
Government Ayurvedic College, Dharashiv |
| Address |
Department of Agad Tantra Avum Vidhi Vaidyakak
Government Ayurvedic College
Dharashiv 413501
Maharashtra India
Devamrut
Near Dakshin Mukhi Maroti Mandir
AP Vihamandwa
Taluka Paithan
District Chhatrapati Sambhajinagar
Maharashtra 431137
Osmanabad
MAHARASHTRA
413501
India |
| Phone |
08975656999 |
| Fax |
|
| Email |
sdhoot1008@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhijit Munshi |
| Designation |
Director Clinical Operations |
| Affiliation |
Alchemy Clinical Research Services |
| Address |
38 LIG So, Somalwada Road
Manish Nagar
Nagpur
MAHARASHTRA
440015
India
Nagpur
MAHARASHTRA
440015
India |
| Phone |
9822371703 |
| Fax |
|
| Email |
drabhijit@alchemyclinical.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubham Ramnarayan Dhoot |
| Designation |
Principal Investigator |
| Affiliation |
Government Ayurvedic College Dharashiv |
| Address |
Department of Agad Tantra Avum Vidhi Vaidyakak
Government Ayurvedic College Dharashiv 413501
Maharashtra
India
Devamrut
Near Dakshin Mukhi Maroti Mandir
AP Vihamandwa
Taluka Paithan
District Chhatrapati Sambhajinagar
Maharashtra 431137
Osmanabad
MAHARASHTRA
413501
India |
| Phone |
08975656999 |
| Fax |
|
| Email |
sdhoot1008@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College, Dharashiv
Maharashtra, 413501
India |
|
|
Primary Sponsor
|
| Name |
Dr. Shubham Ramnarayan Dhoot |
| Address |
Department of Agad Tantra Avum Vidhi Vaidyakak
Government Ayurvedic College
Dharashiv 413501
Maharashtra
India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| R M Dhariwal Foundation |
R M Dhariwal Foundation
Pune |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shubham Ramnarayan Dhoot |
Government Ayurvedic Hospital, Dharashiv |
Vishchikista OPD
Room No 12
Main OPD Building
Government Ayurvedic Hospital
Dharashiv 413501
Maharashtra
India
Osmanabad
MAHARASHTRA |
08975656999
gacraktamrut@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Ayurvedic College Dharashiv |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D67||Hereditary factor IX deficiency. Ayurveda Condition: RAKTAVAHASROTOVIKARAH, (2) ICD-10 Condition:D66||Hereditary factor VIII deficiency. Ayurveda Condition: RAKTAVAHASROTOVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Clotting Factor IX | Recombinant Clotting Factor IX injection, dose as per body weight and clinical requirement, administered IV under physician supervision, frequency and duration as per standard hemophilia protocol. | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Raktamrut Vati, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 180 Days, anupAna/sahapAna: Yes(details: Cow / Goat Milk), Additional Information: Intervention Group 2 will receive Clotting Factor IX, administered intravenously (IV) on an as-needed basis, for a duration of 180 days, along with Raktamrut Vati administered at the specified dose as an adjunct (add-on) therapy. | | 3 | Comparator Arm (Non Ayurveda) | | - | Clotting Factor VIII | Recombinant Clotting Factor VIII injection, dose as per body weight and clinical requirement, administered IV under physician supervision, frequency and duration as per standard hemophilia protocol. | | 4 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Raktamrut Vati, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 180 Days, anupAna/sahapAna: Yes(details: Cow / Goat Milk), Additional Information: Intervention Group 1 will receive Clotting Factor VIII, administered intravenously (IV) on an as-needed basis, for a duration of 180 days, along with Raktamrut Vati administered at the specified dose as an adjunct (add-on) therapy. |
|
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Male |
| Details |
1. Age between 4 to 65 years (both inclusive).
2. Diagnosed with Hemophilia A or B (Factor VIII or IX deficiency), of mild, moderate, or severe type as per standard classification.
3. Currently receiving or eligible to receive standard care therapy (e.g., Clotting Factor VIII or IX).
4. Willing to take Raktamrut Vati as adjunct therapy along with standard treatment.
5. Parent/guardian consent (for participants under 18 years) or written informed consent from adult participants.
6. Willingness to comply with study procedures and follow-up schedule. |
|
| ExclusionCriteria |
| Details |
1. Individuals with bleeding disorders other than hemophilia (e.g., von Willebrand disease, platelet function disorders).
2. History or presence of inhibitors Positive (antibodies) against Clotting Factor VIII or IX.
4. Presence of any other coagulation disorder or significant hematological, hepatic, renal, Neurological or cardiovascular disease.
4. Participation in another interventional clinical trial within the last 30 days.
5. Known hypersensitivity or allergy to any component of Raktamrut Vati or Clotting Factors.
6. Current use of unapproved or investigational herbal products or supplements that could interfere with study results.
7. Severe psychiatric illness or cognitive impairment that interferes with informed consent or compliance.
8. Any other condition, as per investigator’s judgment, that may place the participant at undue risk or affect the validity of the study results. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in dose/frequency of Clotting Factor VIII/IX required |
Baseline to Day 180 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in frequency of bleeding episodes |
Baseline to Day 180 |
| Improvement in Muscle and Joint Health Score (e.g., HJHS, FISH if used) |
Baseline, Day 90, Day 180 |
| Improvement in Hemostatic Score |
Baseline, Day 90, Day 180 |
| Quality of Life improvement (QoL) |
Baseline and Day 180 |
| Reduction in intensity of Pain (by using VAS) |
Baseline to Day 180 |
| Safety and tolerability of Raktamrut Vati Throughout study |
up to Day 180 |
| Hemoglobin and Hematocrit levels |
Baseline, Day 90, Day 180 |
| Improvement in Clotting Time |
Baseline, Day 90, Day 180 |
| Liver and renal function markers (SGOT, SGPT, Creatinine) |
Baseline and Day 180 |
| Change in Plasma Level of Clotting Factor |
Baseline to Day 180 |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
25/07/2025 |
| 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 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response (Others) - For Research Purpose
- By what mechanism will data be made available?
Response - Proposals should be directed to [sdhoot1008@gmail.com].
- For how long will this data be available start date provided 07-04-2026 and end date provided 31-12-2051?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
Brief Summary
Modification(s)
|
This is a prospective, open-label, randomized, four-arm, parallel-group clinical study designed to evaluate the efficacy and safety of Raktamrut Vati as an adjunct therapy in patients with Hemophilia A or B. The study will enroll 100 male participants aged 4 to 65 years diagnosed with mild, moderate, or severe Hemophilia A or B. Each participant will be followed for a duration of 180 days, with visits scheduled as follows: a Screening Visit (Day –7 to Day 0), Randomization and Baseline Visit (Visit 1, Day 0), and four Follow-up Visits on Day 45 (Visit 2), Day 90 (Visit 3), Day 135 (Visit 4), and End of Treatment (Visit 5, Day 180).The primary outcome of the study is the reduction in cumulative clotting factor usage (International Units per month per patient) from baseline to Day 180, as recorded in patient infusion logs and verified through hospital records. Primary efficacy measures include: (1) total clotting factor consumption over 6 months, (2) number of clotting factor infusions required, and (3) time to first bleeding episode post-randomization Eligible participants will be randomized into four groups: Group 1 (Hemophilia B patients receiving standard treatment with Clotting Factor IX), Group 2 (Hemophilia B patients receiving standard treatment with Clotting Factor IX plus Raktamrut Vati), Group 3 (Hemophilia A patients receiving standard treatment with Clotting Factor VIII), and Group 4 (Hemophilia A patients receiving standard treatment with Clotting Factor VIII plus Raktamrut Vati). The allocation ratio within each hemophilia type will be 1:3 (control : intervention). Secondary outcomes include: (1) frequency of bleeding episodes, (2) improvement in joint health score (e.g., Hemophilia Joint Health Score – HJHS), (3) changes in hematological parameters such as hemoglobin and hematocrit, (4) changes in liver and renal function tests (SGOT, SGPT, and serum creatinine), (5) improvement in quality of life assessed by validated hemophilia-specific QoL questionnaires (e.g., Haemo-QoL), and (6) Reduction of intensity of Pain (7) incidence and severity of adverse events related to the study intervention. This study aims to assess whether the addition of Raktamrut Vati to standard factor replacement therapy can reduce clotting factor requirements and improve clinical outcomes without compromising safety in patients with Hemophilia.Raktamrut A Ray of Hope Powered by the Wisdom of Ayurvedic Science
A Tablet of Strength for Every Warrior Living with Hemophilia |