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CTRI Number  CTRI/2023/10/059312 [Registered on: 30/10/2023] Trial Registered Prospectively
Last Modified On: 04/09/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Clinical trial on Sleep problems 
Scientific Title of Study   A prospective open label study to evaluate the safety, efficacy of KAL-HS-05 in the Management of Insomnia (Nidranasha) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
KAL/HS-05/2023 Version 1.0 dated 14th May 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  G R Chandran 
Designation  Principal Investigator  
Affiliation  Kerala Ayurveda Wellness Center 
Address  Ground floor Room Number 1 3282, 12th Main Road, HAL, 2nd Stage, Indiranagar, Bengaluru, Karnataka 560038

Bangalore
KARNATAKA
560038
India 
Phone  9448226574  
Fax    
Email  chandrangr3@gmail.com  
 
Details of Contact Person
Scientific 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  
 
Details of Contact Person
Public 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  
 
Source of Monetary or Material Support  
Kerala Ayurveda Limited Aluva, Kerala - 683 101, India 
 
Primary Sponsor  
Name  Kerala Ayurveda Limited 
Address  Aluva, Kerala - 683 101, India 
Type of Sponsor  Other [Ayurveda company] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr G R Chandran  Kerala Ayurveda Wellness Center  3282, 12th Main Road, Ground Floor Room no 2 HAL, 2nd Stage, Indiranagar, Bengaluru, Karnataka 560038
Bangalore
KARNATAKA 		 9448226574

chandrangr3@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Shettys Hospital Ethics committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G470||Insomnia. Ayurveda Condition: VISUCIKA-UPADRAVAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Nidrakalp (KAL-HS-05), Reference: NA, Route: Oral, Dosage Form: Arishta, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -), Additional Information: The test product Arishtam (KAL-HS-05) will be administered as single shot 30 ml in the morning and 30ml in the evening for a period of 4 consecutive weeks
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Willing to give informed consent.
2. Healthy Indian male/ female volunteer aged between 18-65 years.
3. Must be able to adhere to the study visit schedule and other protocol requirements.
4. Willing to complete the questionnaires for the total duration of treatment.
5. Patients suffering from insomnia/loss of sleep from last 1 month.
6. Willing to avoid usage of any NSAIDs, Sleep inducing medication, etc. during the study duration.
7. Agree not to use any medication (prescription and over the counter), during the course of this study
 
 
ExclusionCriteria 
Details  1. Patients on Psychiatry medicine.
2. Patients on hypnotic medicine or any other drugs known to cause drowsiness.
3. Pregnant or Breast feeding.
4. Inability to provide voluntary consent.
5. Patients with pre-existing severe systemic disease like uncontrolled diabetes, hypertension, and Cardiac illness etc necessitating long term medication.
6. Evidence of significant uncontrolled comorbid disease which in the investigators opinion would jeopardize patient participation.
7. 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.
8. History of cancer, including solid tumors, hematologic malignancies and carcinoma in situ
9. Use of any anti-psychotic drugs for one week prior to Baseline.
10. Subjects who abuse drugs or alcohol drug screening not required.
11. Use of any investigational medication within 4 weeks prior to start of study drug.
12. Greater than moderate alcohol use
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
• % Improvement in sleep quality assessed by Sleep Quality scale[Time: Day 0 to Day 28]]
• % Betterment in the anxiety and stress level assessed by Hamilton’s Anxiety assessment scale. [Time: Day 0 to Day 28]
 		 Day 0 and Day 28 
 
Secondary Outcome  
Outcome  TimePoints 
Safety & vital signs
 		 Day 0 Day 7 Day 14 Day 21 & Day 28  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   30/10/2023 
Date of Study Completion (India) 04/09/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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   Nidranasha can be broadly defined as the loss of sleep or the derangement in the quality and quantity of sleep. Nidranasha or Anidra can also be called as the condition of difficulty in initiating or maintaining sleep. It is the condition also exhibited as waking up early without complete sleep and with the feeling of tiredness and exhaustion. A sound sleep is mainly associated with mental wellness, stress and anxiety may also lead to gradually nidranasha (Insomnia). Acharya Sushrutha also mentions Rajas as the Manasika Dosha leading to Nidranasha (Insomnia) 
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