| CTRI Number |
CTRI/2024/11/076379 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
09/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of Annabhedi Sindooram for Managing Anemia Symptoms in Adults: A Clinical Study |
|
Scientific Title of Study
|
A single-arm clinical trial to evaluate the effect of Annabhedi Sindooram in the management of anemia with reference to hemoglobin percentage |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr J Hareendran Nair |
| Designation |
Managing Director and Founder |
| Affiliation |
Pankajakasthuri Herbal Research Foundation |
| Address |
Pankajakasthuri Herbal Research Foundation Pankajakasthuri Ayurveda Medical college Kattakkada
Thiruvananthapuram
KERALA
695572
India |
| Phone |
|
| Fax |
|
| Email |
hareendrannair@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Jaya Lekshmi |
| Designation |
Deputy Medical Superintendent |
| Affiliation |
Pankajakasthuri Ayurveda Medical college and PG centre |
| Address |
Room No 2
Pankajakasthuri Ayurveda Medical college and PG centre Killy
Pankajakasthuri Herbals India Pvt Ltd.
Poovachal
Thiruvananthapuram
KERALA
695572
India |
| Phone |
8301050260 |
| Fax |
|
| Email |
jayalekshmi.s94@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aparna Chandran |
| Designation |
Assistant professor |
| Affiliation |
Pankajakasthuri Ayurveda Medical college and PG centre |
| Address |
Room No: 2
Department of kayachikitsa
Pankajakasthuri Ayurveda Medical college and PG centre Killy
Thiruvananthapuram
Thiruvananthapuram
KERALA
69972
India |
| Phone |
8075231774 |
| Fax |
|
| Email |
aparnabs94@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pankajakasthuri Herbals India Pvt. Ltd, Poovachal, Trivandrum, Kerala-695575 |
|
|
Primary Sponsor
|
| Name |
Pankajakasthuri Herbals India Pvt Ltd |
| Address |
Poovachal Trivandrum Kerala Pin: 695575 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Kasthuri Nair A |
Pankajakasthuri Ayurveda Medical college and PG centre |
Room No 1 Department of Kayachikitsa Pankajakasthuri Ayurveda Medical college and PG centre Thiruvananthapuram
Thiruvananthapuram
KERALA
Thiruvananthapuram
KERALA |
8113851665
dr.kasthurinair@pkhil.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee of Pankajakasthuri Herbal Research Foundation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D50||Iron deficiency anemia. 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: Annabhedi Sindooram , Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 400(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 180 Days, anupAna/sahapAna: Yes(details: Lime juice), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects with Hb% less than 11 gm/dl.
2. Age group between 18 and 60 years.
|
|
| ExclusionCriteria |
| Details |
1. Anemia secondary to disorders like liver cirrhosis, rheumatoid arthritis, uremia, or malignancies.
2. Sideroblastic anemia, thalassemia major or minor.
3. Iron deficiency anemia in pregnancy.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the change in Hb% over the study period at specific time points. |
Baseline (0th Day): Initial Hb% measurement before the start of treatment.
90th Day: Intermediate Hb% measurement to assess ongoing response.
180th Day (End of Study): Final Hb% measurement to determine the overall effectiveness of the treatment.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Objective Parameters (CBC, Serum Ferritin, Reticulocyte Count)
Subjective Parameters (Fatigue, QoL, Symptom Assessment)
Safety Parameters (LFTs, RFTs, AEs): |
• Objective Parameters (CBC, Serum Ferritin, Reticulocyte Count):
o Assessed at Baseline and 180th Day.
• Subjective Parameters (Fatigue, QoL, Symptom Assessment):
o Evaluated at Baseline 90th Day and 180th Day.
• Safety Parameters (LFTs, RFTs, AEs):
o Measured at Baseline and 180th Day with continuous monitoring for safety concerns throughout the study duration.
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 |
|
Date of First Enrollment (India)
|
18/11/2024 |
| 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="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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 - NO
|
|
Brief Summary
|
Anemia, characterized by a deficiency in red blood cells or hemoglobin, results in inadequate oxygen transport and manifests through symptoms such as fatigue, pallor, weakness, and shortness of breath. In the Ayurvedic context, this condition aligns with Pandu, where the function of Rasadhatvagni is significantly impaired. Various etiologies contribute to anemia, including nutritional deficiencies, chronic diseases, genetic disorders, and bone marrow pathologies. This study is designed as a single-arm clinical interventional trial, with an aim to evaluate the efficacy of Annabhedi Sindooram in improving hemoglobin levels in patients attending the OPD of Pankajakasthuri Ayurveda Medical College Hospital, specifically those with Hb% less than 11 gm/dl. The intervention involves administering Annabhedi Sindooram capsules at a dosage of 1-0-1 (A/F) with lime juice for 180 days. The primary outcome will focus on changes in hemoglobin levels, while secondary outcomes will encompass various subjective and objective measures of anemia, assessed at baseline and at defined intervals. |