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CTRI Number  CTRI/2022/04/041811 [Registered on: 12/04/2022] Trial Registered Prospectively
Last Modified On: 08/04/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Evaluation of safety, tolerability of Septilin Syrup in healthy people.  
Scientific Title of Study   "Safety, tolerability and sensory evaluation of Septilin Syrup in Healthy Volunteers"  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
HWC/MSCD/PP/050/2021, Version Number:1.0; Date: 21FEB2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr S Dinesh  
Designation  Consultant pulmonologist 
Affiliation  Xplora Clinical Research Services Pvt.Ltd 
Address  Xplora Clinical Research Pvt Ltd, Room No.01,Division Clinical Research, Door No. 252, 13th Cross, Wilson Garden,

Bangalore
KARNATAKA
560027
India 
Phone  9886125229  
Fax    
Email  bhaktha.dinesh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Srikrishna 
Designation  Research Scientist 
Affiliation  Himalaya Wellness Company 
Address  302, 3rd floor, clinical pharmacology, R and D, Makali,

Bangalore Rural
KARNATAKA
562162
India 
Phone  08067547230   
Fax    
Email  dr.srikrishna@himalayawellness.com  
 
Details of Contact Person
Public Query  
Name  Suresh Kumar V S 
Designation  Clinical Trial Site Manager 
Affiliation  Himalaya Wellness Company 
Address  302, 3rd floor, clinical pharmacology, R and D, Makali,

Bangalore Rural
KARNATAKA
562162
India 
Phone  08067547233   
Fax    
Email  suresh.kumar@himalayawellness.com  
 
Source of Monetary or Material Support  
Himalaya Wellness Company, Makali, Bengaluru - 562 162 Tel: 080 6754 9919 
 
Primary Sponsor  
Name  Himalaya Wellness Company 
Address  Tumkur road, Makali, bengaluru Bangalore Rural KARNATAKA 562162 India  
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Dinesh S  Xplora Clincal Research Services  Xplora Clincal Research Services Pvt Ltd, Room NO.01,Division-Clinical Research, Door-252, 13th Cross, Wilson Garden, Bangalore-560027 Bangalore KARNATAKA
Bangalore
KARNATAKA 		 9886125229

bhaktha.dinesh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ACE indepedent Ethics commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Septilin, a polyherbal formulation, is recommended for the treatment and management of various infections, and to prevent their recurrence as it has immunomodulatory action 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Septilin Syrup, Reference: NA, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 10(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: Adult dose and Pediatric dose regimen: 10 ml thrice daily oral
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Adult population:
1. Healthy adult subjects of either sex aged between ≥ 18 to ≤ 50 years.
2. Subjects willing to refrain taking any other similar medication during the study period
3. Adult subjects who have not participated in this kind of trial in the past 4 weeks
4. Adult subjects willing to sign informed consent and follow the study procedure.
Pediatric Population:
1. Healthy male and female pediatric subjects aged between ≥2 years to ≤12 years.
2. Parents/Guardians/Caregiver related to pediatric subjects < 7 years willing to give informed consent for his/her child to participate in the study.
3. Pediatric subjects aged > 7 years of age willing to provide oral consent for his/her participation in the study along with parents/guardians/caregiver consent (Refer protocol section 11.4, Informed Consent Process)
4. Pediatric Subjects willing to refrain taking any other similar medication during the study period
5. Pediatric subjects who have not participated in this kind of trial in the past 4 weeks.
6. Parents/ Guardians/ Caregivers of the pediatric subjects willing to sign informed consent/assent (as applicable) and follow the study procedure 
 
ExclusionCriteria 
Details  1. Subjects with clinically significant serious cardiovascular, respiratory,
cerebrovascular, hepatic, renal disease, endocrinal, congenital or any other disorder.
2. A known history or present condition of allergic response to the study products its components or ingredients in the investigational product.
3. Pre-existing systemic disease necessitating long-term medications.
4. Subjects who refused to sign informed consent.
5. Pregnant and lactating women.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Occurrence of any adverse or serious adverse events during the study period.  7 days 
 
Secondary Outcome  
Outcome  TimePoints 
Overall compliance to the study medication   7 days 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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 1 
Date of First Enrollment (India)   20/04/2022 
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="0"
Days="7" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   The neonatal period and infancy are very important periods in the life of an individual. The process of birth suddenly requires the infant to acclimatise and accommodate to the varying physiological and environmental factors necessary for independent functioning and existence. This is the period during which the new born achieves developmental maturity provided nutrition, digestion, metabolism and general care are satisfactory. Any slight disturbances in any of the systems especially the disturbances of the immune system both in children and adults poses difficulty in fighting against any type of systemic infections. This needs more attention and care in both children and adults in order to treat these symptoms related to the systemic infection effectively. Herbal remedies could be of immense benefit to mankind as they possess nature’s own healing powers than many synthetic drugs. Himalaya has committed itself to discover/develop new drugs from traditional Ayurvedic/herbal remedies and folklores. Himalaya has developed a novel polyherbal herbal syrup termed as Septilin Syrup with potent herbal actives. Septilin Syrup subjected to Safety, tolerability and sensory evaluation of Septilin Syrup in healthy adult and pediatric volunteers.

This is an open-label, single-arm, two-period clinical study. Total 12 healthy adult subjects aged between ≥ 18 years to ≤ 50 and 12 healthy pediatric subjects aged between ≥ 2 years to ≤ 12 years will be initiated with the informed consent process followed by screening and enrollment after they fulfill the inclusion criteria. All eligible adult subjects will receive 10 ml Septilin syrup thrice daily oral.

 
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