| CTRI Number |
CTRI/2025/08/093648 [Registered on: 26/08/2025] Trial Registered Prospectively |
| Last Modified On: |
11/05/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Sairub Heal Semi-Solid Ointment and Immunocare Oral Sublingual Drops] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to assess if Sairub Heal and Immunocare drops products are safe and work effectively in individuals with respiratory viral infections |
|
Scientific Title of Study
|
A Single-Center, Open-Label, Clinical Study to evaluate the safety and efficacy of Sairub Heal and Immunocare drops for the treatment of respiratory viral infections |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CTSRS/2516 Version No 1.0 Dated 28 JUN 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manjunath U |
| Designation |
Principal Investigator |
| Affiliation |
Currex Hospital |
| Address |
OPD-5, Ground Floor, Seegehalli Main Rd, Bhoo Samartha Layout, Seegehalli, KS Halli
Bangalore
KARNATAKA
560049
India |
| Phone |
9900282899 |
| Fax |
|
| Email |
drmanju1910@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Sathyavathi LM |
| Designation |
HOD-Clinical Operations |
| Affiliation |
Samahitha Research Solutions |
| Address |
Clinical Research Unit, No.1204, "Ashva", 2nd Floor, 26th Main, Jayanagar 9th Block,
Bangalore
KARNATAKA
560069
India |
| Phone |
9739001749 |
| Fax |
|
| Email |
satyalm@samahitha.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Arpita Malgi |
| Designation |
Team Lead - Clinical Operations |
| Affiliation |
Samahitha Research Solutions |
| Address |
Clinical Research Unit, No.1204, "Ashva", 2nd Floor, 26th Main, Jayanagar 9th Block,
Bangalore
KARNATAKA
560069
India |
| Phone |
6364898825 |
| Fax |
|
| Email |
arpita@samahitha.com |
|
|
Source of Monetary or Material Support
|
| Saisa Medi LLP
Plot No: 5-6, Sector 3, Industrial Area,
Parwanoo,
Solan, Pin Code - 173220, Himachal Pradesh.
|
|
|
Primary Sponsor
|
| Name |
Saisa Medi LLP |
| Address |
Plot No.: 5-6, Sector 3, Industrial Area,
Parwanoo,
Solan 173220, Himachal Pradesh.
|
| 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 Manjunath U |
Currex Hospital |
OPD-5, Ground Floor, Seegehalli Main Rd, Bhoo Samartha Layout, Seegehalli, KS Halli,
Bangalore
KARNATAKA |
9900282899
drmanju1910@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pranav Diabetes Center Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J069||Acute upper respiratory infection,unspecified. Ayurveda Condition: SVASAH, (2) ICD-10 Condition:J111||Influenza due to unidentified influenza virus with other respiratory manifestations. Ayurveda Condition: SVASAH, (3) ICD-10 Condition:J129||Viral pneumonia, unspecified. Ayurveda Condition: SVASAH, (4) ICD-10 Condition:J209||Acute bronchitis, unspecified. Ayurveda Condition: SVASAH, (5) ICD-10 Condition:J22||Unspecified acute lower respiratory infection. Ayurveda Condition: SVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Immunodrops, Reference: NA, Route: Oral, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -), Additional Information: Administer 9 drops under the tongue sublingually twice daily morning and
evening. Participants are instructed not to eat or drink for at least 10 minutes post administration. | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Sairub Heal, Reference: NA, Route: Nasal, Dosage Form: Malahara/ Ointment/ Balm, Dose: 100(g), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -), Additional Information: -Steam Inhalation: Add a very small amount (equivalent to two grains of wheat)
using the plastic spatula provided into boiling water. Inhale steam for 5–7 minutes,
three times a day.
-Palm Inhalation: Apply a small quantity to palms, rub gently, and perform alternate
nostril inhalation:
o Inhale through the nose, exhale through the mouth → Inhale through the
mouth, exhale through the nose.
o Repeat this 9 times, 3–4 times a day.
-Topical Application: Apply to the forehead, chest, and back before bedtime. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Male or female subjects aged 18 to 70 years.
2.Clinical diagnosis of respiratory viral infection including:
a.Recent onset less than or equal to 2 days of bronchial mucus production with impaired cough.
b.Presence of respiratory symptoms for example - runny nose, cough, throat irritation or tickling.
c.Presence of systemic symptoms for example - weakness, myalgia, headache, chills, sweating.
d.Symptoms such as fever, productive cough, dyspnea, or chest pain with oxygen saturation SpO2 greater than or equal to 94 percent on room air.
e.Symptom frequency of more than once a week but less than once a day for example- wheeze, cough, breathlessness.
3.FEV1 greater than or equal to 60 percent predicted at screening.
4.Reversible airway obstruction confirmed by greater than or equal to 12 percent improvement in FEV1 post bronchodilator.
5.Ability and willingness to comply with study procedures and visit schedule.
6.Willingness to abstain from other respiratory treatments during the study, unless medically necessary.
7.Written informed consent obtained prior to any study related procedure.
|
|
| ExclusionCriteria |
| Details |
1.Requirement for antiviral medications during the study period.
2.Known primary or secondary immunodeficiency for example- HIV, immunosuppressive therapy.
3.History or suspicion of malignancy except benign neoplasms.
4.Active tuberculosis or other concurrent infections requiring antibiotic therapy.
5.Presence of aggravated or decompensated chronic disease that could interfere with study compliance.
6.Diagnosed malabsorption syndromes, including lactase or disaccharidase deficiency, galactosemia.
7.Known allergy or hypersensitivity to any components of Sairub Heal or Immunocare Drops.
8.Pregnancy or breastfeeding;recent childbirth within 3 months prior to enrollment.
9.Unwillingness or inability to use acceptable contraceptive methods during the study period.
10.Participation in another interventional clinical trial within the last 30 days.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Change in Forced Expiratory Volume in 1 Second (FEV1).
2.Change in Peak Expiratory Flow Rate (PEFR).
3.Change in Oxygen Saturation (SpO2).
4.PCR-confirmed incidence of respiratory viral infection. |
Day 0, Day7 , Day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Change in Serum Immunoglobulin G (IgG) levels.
2.Patient Global Impression of Change (PGIC).
3.Incidence and severity of Adverse Events (AEs).
4.Changes in vital signs.
5.Physical examination findings. |
Day 0, Day 7, Day 14 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
05/09/2025 |
| Date of Study Completion (India) |
28/09/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="14" |
|
Recruitment Status of Trial (Global)
|
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
Modification(s)
|
Result of the Study: This open label single arm single center prospective clinical study demonstrated that treatment with Sairub Heal ointment in combination with Immunocare Drops was clinically effective well tolerated and safe in subjects with Allergic Rhinitis Sinusitis and Respiratory Viral Infections over a 14 day treatment period Across primary efficacy endpoints the study showed a clinically meaningful and consistent reduction in composite respiratory symptom severity accompanied by objective improvements in pulmonary function PEFR and systemic oxygenation SpO2 These findings indicate not only symptomatic relief but also measurable enhancement in respiratory physiology The consistency of improvements and low variability across participants support the robustness of the observed treatment response Patient reported outcomes further corroborated these findings demonstrating sustained improvements in respiratory symptoms cough severity energy levels daily functioning and sleep quality The progressive improvement from Day 7 to Day 14 suggests a cumulative therapeutic benefit with continued treatment. |