| CTRI Number |
CTRI/2022/11/047555 [Registered on: 23/11/2022] Trial Registered Prospectively |
| Last Modified On: |
23/11/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical trial on Kerala Ayurveda product in Tiredness subjects |
|
Scientific Title of Study
|
A prospective, interventional, open-label clinical study to evaluate the safety and efficacy of KAL-HS-02 in reducing fatigue (Shrama), tiredness (Klama), improving strength (Balya), energy (Urjas) and enhancing quality of life (Swasthakara) among adult volunteers |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| KAL-HS-02 Version 1.0 Dated 01 Sep 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSarala Samuel |
| Designation |
Vice president -Research and Development |
| Affiliation |
Kerala Ayurveda Ltd. |
| Address |
Research and Development Department second floor Athani Post, Aluva, Ernakulam District, Kerala – India
Ernakulam
KERALA
683585
India |
| Phone |
9895517764 |
| Fax |
|
| Email |
sarala@keralaayurveda.biz |
|
Details of Contact Person
Scientific Query
|
| Name |
Jayashree M |
| Designation |
Senior Scientific officer |
| Affiliation |
Kerala Ayurveda Ltd. |
| Address |
Research and Development Department second floor Athani Post, Aluva, Ernakulam District, Kerala – India
Ernakulam
KERALA
683585
India |
| Phone |
9880677814 |
| Fax |
|
| Email |
jayashree@keralaayurveda.us |
|
Details of Contact Person
Public Query
|
| Name |
DrSarala Samuel |
| Designation |
Vice president -Research and Development |
| Affiliation |
Kerala Ayurveda Ltd. |
| Address |
Research and Development Department second floor Athani Post, Aluva, Ernakulam District, Kerala – India
Ernakulam
KERALA
683585
India |
| Phone |
9895517764 |
| Fax |
|
| Email |
sarala@keralaayurveda.biz |
|
|
Source of Monetary or Material Support
|
| Kerala Ayurveda Limited
Registered Office – Head Office
Athani Post, Aluva,
Ernakulam District, Kerala – 683585, India
|
|
|
Primary Sponsor
|
| Name |
Kerala Ayurveda Limited |
| Address |
– Head Office Athani Post, Aluva, Ernakulam District, Kerala – 683585, India |
| Type of Sponsor |
Other [Ayurveda and wellness product manufacturing and marketing company ] |
|
|
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 |
| DrShubarani |
Sushrutha Ayurvedic Medical College And Hospital |
Ground floor room number 3 Prashanti Kuteera jodi Bingipura, Jigani Hobli, Anekal, Taluk, Bengaluru, Karnataka 560105
Bangalore
KARNATAKA |
9449456743
dr.shubharani111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Venkateshwara Hospitals Ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R531||Weakness. Ayurveda Condition: Shrama,Klama,Balya,Urjas and Swasthakara, (2) ICD-10 Condition:R531||Weakness. Ayurveda Condition: KLAMAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: KAL-HS-02 (CLEAN), Reference: AYURVEDIC PHARMACOPOEIA OF INDIA, Route: Oral, Dosage Form: Arishta, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: -), Additional Information: NIL | | 2 | Comparator Arm (Non Ayurveda) | | - | Not applicable | Not applicable |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 18 to 60 years
2. Both male and female
3. Subject meet criteria for fatigue as per Chalder Fatigue Assessment scale.
4. Subjects willing and able to provide informed consent voluntarily
5. Patient is willing and able to comply with all trial requirements |
|
| ExclusionCriteria |
| Details |
1. Pregnant or Breast feeding.
2. Inability to provide voluntary consent.
3. Volunteers who have participated in any drug research study within past 3 months
4. Patients with pre existing severe systemic disease like uncontrolled diabetes, hypertension, and Cardiac illness etc necessitating long term medication.
5. Evidence of significant uncontrolled co morbid disease which in the investigators opinion would jeopardize patient participation.
6. Any clinically significant medical history, medical finding or an ongoing medical or psychiatric condition exists which in the opinion of the Investigator could jeopardize the safety of the subject, impact validity of the study results or interfere with the completion of study according to the protocol.
7. History of cancer, including solid tumors, hematologic malignancies and carcinoma in situ
8. Use of any anti psychotic drugs in the past.
9. Subjects who abuse drugs or alcohol
10. Use of any investigational medication within 4 weeks prior to start of study drug
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. % Improvement in Chalder Fatigue Scale (CFQ 11) (Time points: Baseline, Day 7, Day 14, Day 28)
2. % Improvement in energy/fatigue scale of the RAND-36 questionnaire. (Time points: Baseline, Day 7, Day 14, Day 28)
|
Day 0day 7 ,Da 14 and Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Assessment of Total energy expenditure and Physical Activity (IPAQ Questionnaire) |
Baseline (Day 0) and Day 28 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
25/11/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Fatigue is a most common
condition observed in general population. However, the definitive management of
fatigue, tiredness, low energy syndrome is vaguely defined, Ayurveda, the
Indian traditional system of medicine, is one of the world’s oldest medicine systems
which has defined management with well-known herbs used from ancient times with
proven safety and efficacy. Hence the present study is designed to evaluate the
safety and efficacy of this unique herbal combination in fatigue, tiredness and
low energy as a holistic approach. This unique herbal formulation has multiple
active ingredients with multiple mechanism of actions. These ingredients are used
in India and Asian countries from many centuries and having vast literature on
their safety and efficacy. The active ingredients in this formulation are Woodfordia
fruiticosa, Vitis vinifera, Madhuca indica, Cyperus rotundus, Hemidesmus
indicus, Nelumbo nucifera, Emblica offcinalis, Sphaeranthus Indicus, Tinospora
cordifolia, Terminalia chebula, Acacia catechu, Piper nigrum, Curcuma longa,
Messua ferrea, Rubia cordifolia, Inula racemose, Apium graveolens, Terminalia
belerica, Piper longum, Embelia ribes, Elettaria cardamomum, Syzygium
aromaticum, Cinnamomum zeylanicum, Jaggery and Honey. |