| CTRI Number |
CTRI/2024/10/075257 [Registered on: 15/10/2024] Trial Registered Prospectively |
| Last Modified On: |
24/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical study for safety and efficacy of HimalcaTM on Improvement of Cognitive Function in adults aged between 55 to 80 years for both male and female patients. |
|
Scientific Title of Study
|
Efficacy and Safety of HimalcaTM on Improvement of Cognitive Function: A 12-week, Prospective, Randomized, Double-blind, Placebo controlled Clinical Study. |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 21PR0157-008 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Guru Prakash K V |
| Designation |
Consultant Psychiatrist |
| Affiliation |
Spandana Hospital |
| Address |
Spandana Hospital Pvt Ltd
No-1 of 1 Mysore Rd Pantarapalya opposite Nayanda Halli metro station Bengaluru
Bangalore
KARNATAKA
560039
India |
| Phone |
9449816740 |
| Fax |
|
| Email |
nimmaguru@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arabinda Patnaik |
| Designation |
Associate Director, Project Operations |
| Affiliation |
Syncorp Health Pvt. Ltd. |
| Address |
No 6 3rd Floor second Main Road sarvobhaogam Nagar Arekere
Bangalore
Bangalore
KARNATAKA
560076
India |
| Phone |
9014308214 |
| Fax |
|
| Email |
arvind.p@syncorphealth.com |
|
Details of Contact Person
Public Query
|
| Name |
Arabinda Patnaik |
| Designation |
Associate Director, Project Operations |
| Affiliation |
Syncorp Health Pvt. Ltd. |
| Address |
No 6 3rd Floor second Main Road sarvobhaogam Nagar Arekere
Bangalore
Bangalore
KARNATAKA
560076
India |
| Phone |
9014308214 |
| Fax |
|
| Email |
arvind.p@syncorphealth.com |
|
|
Source of Monetary or Material Support
|
| Spandana Hospital,
No-1/1, Mysore Rd, Pantarapalya, opposite Nayanda Halli metro station, Bengaluru, Karnataka 560039 |
|
Primary Sponsor
Modification(s)
|
| Name |
THREE H LABS Co Ltd |
| Address |
2204,Kintex Kkumegreen Office Building, 240,Kintex-ro, Ilsanseo-gu, Goyang-Si, Gyeonggi-do, 10391,Republic of Korea |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 Gur Prakash K v |
Spandana Hospital |
Department of Psychiatry room no 3 ground floor No-1 of 1 Mysore Rd Pantarapalya opposite Nayanda Halli metro station Bengaluru Karnataka 560039
Bangalore
KARNATAKA |
9449816740
nimmaguru@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Durgamba Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G319||Degenerative disease of nervous system, unspecified. Ayurveda Condition: SVABAVIKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Centella asiatica , Reference: Centella asiatica , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 300(mg), Frequency: od, Bhaishajya Kal: Grasantara bhakta, Duration: 84 Days, anupAna/sahapAna: Yes(details: -), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Placebo | Medicine Name: Placebo Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 300(mg), Frequency: od, Bhaishajya Kal: Grasantara bhakta, Duration: 84 Days, |
|
|
|
Inclusion Criteria
|
| Age From |
55.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and Female individuals aged from 55 to 80 years (both inclusive).
2. Without hearing, visual impairment and other communication disorders.
3. Those who meet the requirement of Montreal Cognitive Assessment Score of 19 to 25.
4. Literate subjects.
5. Those who voluntarily agree to participate and sign the informed consent form.
|
|
| ExclusionCriteria |
| Details |
1. Known history of hypersensitivity to any drugs, herbal extracts or dietary supplements.
2. Those with a history of having received any investigational drug or participated in any other clinical trial which ended in the preceding 3 months or are currently ongoing.
3. On-going treatment with herbals or allopathic drugs (cholinesterase inhibitors) for MCI.
4. History of seizures.
5. Head trauma with loss of consciousness.
6. Diagnosed psychiatric disorders including dissociative disorder, obsessive-compulsive disorder, personality disorders, schizophrenia, bipolar disorder.
7. Those consuming drugs amitriptyline, Aripiprazole, Benztropine, Biperiden, Brompheniramine, Carbamazepine, Chlorpheniramine, Chlorpromazine that affect cognitive performance like within 3 months prior to screening.
8. Those who are unable to communicate daily due to impaired vision, hearing, and unable to write due to physical disability.
9. Those who are taking drugs including antihistamine, non-steroid anti-inflammation, hormonal drugs, anti-biotics, etc.
10. Those who have undergone surgery within 6 months prior to screening.
11. Those with severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), heart disease (Angina pectoris, myocardial infarction, heart failure, arrhythmia in need of treatment), lung disease (chronic obstructive pulmonary disease, etc.) within the last 6 months (However, those who are clinically stable may participate in the trial on the investigator’ discretion).
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Changes from pre- & post-treatment on mental status and cognitive function assessed by Montreal Cognitive Assessment (MoCA).
2. Change from pre- & post-treatment on cognitive function assessed by Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog). |
1. Baseline and Week 12
2. Baseline and Week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in pre - & post-treatment Brain Derived Neurotrophic Factor.
2. Changes from pre- & post-treatment as assessed by individual tasks in Alzheimer’s Disease Assessment Scale – Cognitive Subscale (ADAS-Cog) including 1) Word Recall, 2) Commands, 3) Constructional Praxis, 4) Naming, 5) Ideational Praxis, 6) Orientation, 7) Word Recognition, 8) Remembering Word Recognition Test Instructions, 9) Comprehension of Spoken Language, 10) Word-Finding Ability, and 11) Spoken Language Ability. |
1. Baseline and Week 12
2. Baseline and Week 12 |
|
|
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)
|
24/10/2024 |
| 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="1"
Months="2"
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
|
Dementia represents a serious public health challenge for elderly people,
while Alzheimer’s disease (AD), the most common type of dementia, has become
one of the biggest mental burdens .
Except for the recent and controversial approval of Aduhelm to treat patients
with Alzheimer’s disease, there are no effective treatments to prevent or delay
its progression, only for treating the symptoms of mild to moderate dementia.
Therefore, there is an urgent need to identify effective strategies to prevent
dementia. It is well recognized that mild cognitive impairment (MCI) precedes
AD ;
however, new evidence suggests that subtle and silent pathological brain
changes associated with subjective decline are also present in subjects with
subjective cognitive decline (SCD), defined as a self-reported decline in
cognitive performance compared to an individual’s previous level of
functioning, which cannot be determined by neuropsychological tests and precedes objective cognitive decline Mild
cognitive impairment (MCI) most simplistically defined refers to cognitive
changes in the absence of dementia. It has been likened to an intermediate
stage between normalcy and dementia. Indeed, the entity probably stemmed from
the pursuit of clinicians to try and find the missing piece of the puzzle
between so called “normal†elderly and the elder with dementia.
Reisberg
in 1988 first described an entity with Global Deterioration
Scale Score (GDS) of 3. Subsequently, Flicker and colleagues wrote an article on patients at risk for dementia, also with GDS scores of 3.
Of course, it was Peterson in 1997, who then termed this entity
as Mild Cognitive Impairment or MCI.
Currently
approved treatment for MCI is purely symptomatic. Registered symptomatic
treatment consists of acetylcholinesterase inhibitors (AchE-Is) and memantine.
AchE-Is in general.
There is
an ongoing effort in the development of more effective symptomatic treatment
options, new compounds which are natural extracts with a potential to improve
the symptoms of cognitive decline in aging adults are in the center of interest
in the research field. However, no natural extract supplement with a robust
data has proven the potential to improve the symptoms, restore the cognition
and cease the progression into AD is presently available, has been designed to
evaluate in improving existing mild cognition deficits and the ability to
better perform activities of daily living which would provide a substantial
benefit to patients.
|