CTRI/2026/01/100782 [Registered on: 09/01/2026] Trial Registered Prospectively
Last Modified On:
09/01/2026
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Drug Ayurveda Preventive
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A Study on the Effect of Hydrotherapy( Hot foot and arm bath) along with Standard Treatment in Children with Asthma
Scientific Title of Study
A Comparative Study To Evaluate the Efficacy of Hydrotherapy(Hot Foot and Arm Bath) with Standard Treatment in Management of Childhood Bronchial Asthma-A Randomized Controlled Trial
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Neha Sharma
Designation
PG SCHOLAR
Affiliation
Chaudhary Brahm Prakash Ayurved Charak Sansthan
Address
Room no 222 PG Department Of Swasthvritta And Yoga Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh New Delhi Room no 222 PG Department Of Swasthvritta And Yoga Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh New Delhi South West DELHI 110073 India
Phone
9717254642
Fax
Email
nehasmart1999@gmail.com
Details of Contact Person Scientific Query
Name
Dr Rakesh Kumar Verma
Designation
Professor
Affiliation
Ch. Brahm Prakash Ayurved Charak Sansthan
Address
Room No.233, Ch. Brahm Prakash Ayurved Charak Sansthan Khera Dabar, Najafgarh
South West
DELHI
110073
India
Room No.233, Ch. Brahm Prakash Ayurved Charak Sansthan Khera Dabar, Najafgarh
South West
DELHI
110073
India
South West DELHI 110073 India
Phone
9990149662
Fax
Email
rakeshverma2399@gmail.com
Details of Contact Person Public Query
Name
Dr Rakesh Kumar Verma
Designation
Professor
Affiliation
Ch. Brahm Prakash Ayurved Charak Sansthan
Address
Room No.233, Ch. Brahm Prakash Ayurved Charak Sansthan Khera Dabar, Najafgarh
South West
DELHI
110073
India
Room No.233, Ch. Brahm Prakash Ayurved Charak Sansthan Khera Dabar, Najafgarh
South West
DELHI
110073
India
South West DELHI 110073 India
(Procedure Reference: Maheshkumar K, Pandiaraja M, Venugopal V, Poonguzhali S, Sundareswaran L. Effects of hot foot and arm bath in bronchial asthma: A single case report. Foot (Edinb). 2020 Mar;42:101651, Procedure details: Preparation
1.Explain the procedure to the child and caregiver.
2.Check baseline vitals: temperature, respiratory rate.
3.Ensure the child is seated comfortably.
4.Fill the foot and arm tubs with warm water (40–45 Degree celsius).
6.Temperature measurement method -Test the water temperature with a water proof thermometer before immersing limbs.
Administration
1.Immerse the child’s feet up to the ankles and arms up to the elbows in warm water.
2.Cover the child with a towel or blanket if they feel cold.
3.Duration: 15–20 minutes, ensuring child comfort throughout.
4.Use cold compress to head when sweating begins.
5.Continuously monitor water temperature with waterproof thermometer and child’s reaction.
6.Method of maintaining the temperature of water-Gently stir the water occasionally and pour hot water in container by continuous measuring the temperature of water with thermometer throughout the procedure to maintain warmth.
7.Offer sips of water if the child feels thirsty.
After the Procedure
1.Remove limbs from water.
2.Dry the feet and arms thoroughly.
3.Allow the child to rest for 10 minutes post-therapy.
4.Note any adverse events or discomfort.) (1) Medicine Name: 1.Talisadi churn , Reference: Ministry of AYUSH. Ayurvedic Standard Treatment Guidelines. 1st ed. New Delhi: Government of India; 2017, Route: Oral, Dosage Form: Churna/ Powder, Dose: 100(mg), Frequency: bd, Duration: 2 Months(2) Medicine Name: 2.Dashmool kwath , Reference: Ministry of AYUSH. Ayurvedic Standard Treatment Guidelines. 1st ed. New Delhi: Government of India; 2017, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 1.5(ml), Frequency: bd, Duration: 2 Months(3) Medicine Name: 3.Swasa kuthar rasa , Reference: Ministry of AYUSH. Ayurvedic Standard Treatment Guidelines. 1st ed. New Delhi: Government of India; 2017, Route: Oral, Dosage Form: Rasayoga, Dose: 10(mg), Frequency: bd, Duration: 2 Months(4) Medicine Name: 4.Vasa avleha , Reference: Ministry of AYUSH. Ayurvedic Standard Treatment Guidelines. 1st ed. New Delhi: Government of India; 2017, Route: Oral, Dosage Form: Rasayoga, Dose: 0.5(ml), Frequency: bd, Duration: 2 Months(5) Medicine Name: 1.Talisadi churn, sunthi churn, ,somlata churn, Reference: Ministry of AYUSH. Ayurvedic Standard Treatment Guidelines. 1st ed. New Delhi: Government of India; 2017, Route: Oral, Dosage Form: Churna/ Powder, Dose: 200(mg), Frequency: bd, Duration: 2 Months(6) Medicine Name: 2.Nayopayam kwath , Reference: Ministry of AYUSH. Ayurvedic Standard Treatment Guidelines. 1st ed. New Delhi: Government of India; 2017, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 1.5(ml), Frequency: bd, Duration: 2 Months(7) Medicine Name: 3.vayu gutika , Reference: Ministry of AYUSH. Ayurvedic Standard Treatment Guidelines. 1st ed. New Delhi: Government of India; 2017, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 10(mg), Frequency: bd, Duration: 2 Months(8) Medicine Name: 4.kantakari avleha, Reference: Ministry of AYUSH. Ayurvedic Standard Treatment Guidelines. 1st ed. New Delhi: Government of India; 2017, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 0.5(ml), Frequency: bd, Duration: 2 Months
2
Comparator Arm
Drug
Classical
(1) Medicine Name: 1.Talisadi churn , Reference: Ministry of AYUSH. Ayurvedic Standard Treatment Guidelines. 1st ed. New Delhi: Government of India; 2017, Route: Oral, Dosage Form: Churna/ Powder, Dose: 100(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: 2.Dashmool kwath, Reference: Ministry of AYUSH. Ayurvedic Standard Treatment Guidelines. 1st ed. New Delhi: Government of India; 2017, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 1.5(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: -(3) Medicine Name: 3.Swasa kuthar rasa , Reference: Ministry of AYUSH. Ayurvedic Standard Treatment Guidelines. 1st ed. New Delhi: Government of India; 2017, Route: Oral, Dosage Form: Rasayoga, Dose: 10(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: -(4) Medicine Name: 4.Vasa avleha, Reference: Ministry of AYUSH. Ayurvedic Standard Treatment Guidelines. 1st ed. New Delhi: Government of India; 2017, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 0.5(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: -(5) Medicine Name: 1.Talisadi churn, sunthi churn, ,somlata churn, Reference: Ministry of AYUSH. Ayurvedic Standard Treatment Guidelines. 1st ed. New Delhi: Government of India; 2017, Route: Oral, Dosage Form: Churna/ Powder, Dose: 200(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: -(6) Medicine Name: 2.Nayopayam kwath, Reference: Ministry of AYUSH. Ayurvedic Standard Treatment Guidelines. 1st ed. New Delhi: Government of India; 2017, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 1.5(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: -(7) Medicine Name: 3.vayu gutika, Reference: Ministry of AYUSH. Ayurvedic Standard Treatment Guidelines. 1st ed. New Delhi: Government of India; 2017, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 10(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: -(8) Medicine Name: 4.kantakari avleha, Reference: Ministry of AYUSH. Ayurvedic Standard Treatment Guidelines. 1st ed. New Delhi: Government of India; 2017, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 0.5(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: -
Inclusion Criteria
Age From
7.00 Year(s)
Age To
16.00 Year(s)
Gender
Both
Details
1.Age group – 7-16 yrs.
2.Mild to Moderate asthmatic patients.
3.Able to perform spirometry and other test.
4.Parents are willing to participate in the full duration of the intervention and follow-up of their children
ExclusionCriteria
Details
1.Severe asthmatic patients.
2.Acute asthma exacerbation within the last 4 weeks.
3.Patients with known cases of complicated respiratory disorders like bronchiectasis, TB, etc.
4.Physical or Cognitive Impairment: Inability to follow instructions or participate in therapy sessions.
5.Any history of life-threatening allergic reactions.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Other
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
•Improvement in symptoms of asthma.
•Significant improvement in spirometry (FVC, FEV1) values.
1st assessment on day 1, 2nd assessment on day
Secondary Outcome
Outcome
TimePoints
•Improved Quality of Life
Assessed using pediatric asthma quality of life questionnaire (PAQLQ)(S).
1st assessment on day 0, 2nd assessment on day 60
•Reduced Use of Rescue Medication
Fewer episodes requiring bronchodilators or inhalers.
assessment on day 60
•Better Sleep Quality and Reduced Nighttime Symptoms
Decreased nighttime coughing, wheezing and breathlessness.
assessment on day 20, day 40, day 60
Target Sample Size
Total Sample Size="64" Sample Size from India="64" 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 2
Date of First Enrollment (India)
05/03/2026
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="0" 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
In this RCT we evaluate the efficacy of hydrotherapy (Hot foot and arm bath) as an adjunct to standard treatment in the management of childhood bronchial asthma correlating with Tamaka Shwasa described in ayurveda. The study is designed as an open label randomized comparative clinical trial to be conducted at ch. brahm prakash ayurveda charak sansthan new delhi. A total of 64 children aged 7 to 16 years diagnosed with mild to moderate bronchial asthma will be recruited and randomly allocated into two groups.
Group A will receive standard ayurvedic treatment along with HFAB. Group B will receive standard ayurvedic treatment alone. HFAB will be administered for 2 months, three times per week, with regular follow ups on the 20th, 40th, 60th days. Hydrotherapy particularly HFAB is traditionally used in naturopathy and is believed to improve symptoms of asthma. Primary outcome is to improve pulmonary function tests(FEV1 and FVC) .