| CTRI Number |
CTRI/2025/11/097679 [Registered on: 18/11/2025] Trial Registered Prospectively |
| Last Modified On: |
02/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
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Public Title of Study
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Evaluating the effectiveness of Virechana Karma and Rasayana therapy in improving respiratory and bowel symptoms in patients with Allergic bronchial Asthma associated with functional constipation |
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Scientific Title of Study
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Clinical Efficacy of Virechana Karma and Rasayana therapy in the management of Udavartajanya Santamaka Shwasa (Allergic bronchial asthma associated with functional constipation)-An exploratory single-arm clinical trial |
| Trial Acronym |
NIL |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Haritha T |
| Designation |
MD Scholar, Department of Kayachikitsa |
| Affiliation |
All India Institute Of Ayurveda |
| Address |
Department of Kayachikitsa, 6th floor, Academic block, Block C, All India Institute Of Ayurveda, Gautampuri awaas, Sarita Vihar, Mathura road, South Delhi, New Delhi
South
DELHI
110076
India |
| Phone |
9072905183 |
| Fax |
|
| Email |
harithaharichandanam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya Kajaria |
| Designation |
Associate Professor, Department of Kayachikitsa |
| Affiliation |
All India Institute Of Ayurveda |
| Address |
Department of Kayachikitsa, 6th floor, Academic block, Block C, All India Institute Of Ayurveda, Gautampuri awaas, Sarita Vihar, Mathura road, South Delhi, New Delhi
South
DELHI
110076
India |
| Phone |
8826167515 |
| Fax |
|
| Email |
kajariadivya5@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Haritha T |
| Designation |
MD Scholar, Department of Kayachikitsa |
| Affiliation |
All India Institute Of Ayurveda |
| Address |
Department of Kayachikitsa, 6th floor, Academic block, Block C, All India Institute Of Ayurveda, Gautampuri awaas, Sarita Vihar, Mathura road, South Delhi, New Delhi
South
DELHI
110076
India |
| Phone |
9072905183 |
| Fax |
|
| Email |
harithaharichandanam@gmail.com |
|
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Source of Monetary or Material Support
|
| All India Institute Of Ayurveda |
|
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Primary Sponsor
|
| Name |
All India Institute Of Ayurveda |
| Address |
All India Institute Of Ayurveda, Gautampuri awaas, Sarita Vihar, Mathura road, South Delhi 110076 |
| Type of Sponsor |
Research institution and hospital |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Haritha T |
All India Institute Of Ayurveda |
Department of Kayachikitsa,OPD no.1, Ground floor, Hospital block,All India Institute Of Ayurveda, Gautampuri awaas, Sarita Vihar, Mathura road, South Delhi, New Delhi 110076
South
DELHI |
9072905183
harithaharichandanam@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee,All India Institute Of Ayurveda,New Delhi |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K590||Constipation. Ayurveda Condition: UDAVARTAH, (2) ICD-10 Condition:J454||Moderate persistent asthma. Ayurveda Condition: SANTAMAKASVASAH, |
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-कर्म Pradhan Karma | (Procedure Reference: Cha.Chi.17/21, Procedure details: Administration of virechana medicine for 1 day)
(1) Medicine Name: Trivrit churna soaked in swarasa of matulunga and hingu churna,saindhava lavana with phalatrikadi kwath and kutaki churna, Reference: AH.Chi.4/6-7,Sarvanga sundara vyakhya, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: od, Duration: 1 Days |
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Inclusion Criteria
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| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of all genders between 21 and 60 years.
2.Patients having classical features of Santamaka shwasa as well as Udavarta. A history of variable respiratory symptoms including wheeze, shortness of breath, chest tightness and cough.
3.Positive Reversibility Test: Evidence of reversible airway obstruction, as defined by an increase in FEV1 of greater than 200ml or greater than or equal to 12 percent of the pre-bronchodilator value between 20 to 30 minutes after 4 puffs (or less at the discretion of the investigator) of inhaled short-acting beta-agonist administration at Visit 0.
4.FEV1/FVC ratio is less than 80 percent of predictive value. Severity as Mild to Moderate stable asthma defined as FEV1 between 60 percent to 80 percent of the predicted value.
5.Total serum IgE concentration greater than or equal to 130 and less than or equal to 700 IU/mL at Visit 0.
6.Patients presenting with functional constipation diagnosed as per ROME IV criteria.
7.Patients eligible for Virechana Karma.
8.Patients who are willing to participate in the study with informed written consent. |
|
| ExclusionCriteria |
| Details |
1.Evidence of active concomitant pulmonary diseases other than asthma like TB, pneumonia, etc.
2.Patients taking steroid therapy (systemic or inhaled).
3.Concomitant severe systemic disease (cardiovascular, renal, hepatic, endocrine, haematological, neurological, immunological).
4.Diagnosed cases of Hypothyroidism and Irritable bowel syndrome.
5.Patients with uncontrolled Type 2 Diabetes mellitus (HbA1c greater than 7 percent), Grade 2 Hypertension or more.
6.Past or current malignancy.
7.Pregnant ladies and lactating mothers.
8.History of any adverse drug reactions to any ingredient of the drug.
9.Patients having positive HIV1 and 2 or positive Hepatitis B.
10.Patients on medications such as antacids/iron supplements/laxatives/NSAIDS/Anti histamines/diuretics/anti psychotics.
11.Patients who participated in other clinical trials in past 12 weeks.
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Change in FEV1, FEV1/FVC, FVC & PEFR. |
Assessment of signs and symptoms at baseline, after Virechana, after rasayana and after follow up of 1 month |
|
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Secondary Outcome
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| Outcome |
TimePoints |
Changes in the sign and symptoms of Santamaka Shwasa and udavarta.
Change in IgE level and AEC level.
Change in Constipation Assessment Score- Wexner constipation score & Patient’s Assessment of Constipation Symptoms questionnaire Score.
Change in Modified Medical Research Council (mMRC) dyspnoea scale. |
Assessment of signs and symptoms at baseline, after Virechana, after rasayana and after follow up of 1 month |
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Target Sample Size
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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" |
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Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/12/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Allergic Bronchial Asthma is a chronic inflammatory disorder with high prevalence, frequent relapses, and suboptimal control despite modern treatments. In Ayurveda, it aligns with Tamaka Shwasa, a Vata Kaphaja Yapya Vyadhi, where Udavarta, the vitiation of Vata causing pratiloma gati in the body, plays a key role in its pathogenesis and chronicity. While Udavarta has no direct parallel in modern medicine, functional constipation can be considered a clinical correlate, frequently observed but overlooked in asthma management. Emerging evidence on the gut lung axis supports this Ayurvedic perspective, highlighting the influence of gastrointestinal health on respiratory disorders. However, there is a significant research gap, as no clinical studies have explored the integrated management of Allergic Bronchial Asthma with functional constipation through Virechana Karma and Rasayana therapy. This study aims to address this unmet need.
RESEARCH QUESTION Does Virechana Karma and Rasayana therapy improve clinical outcomes in patients of Udavartajanya Santamaka Shwasa (Allergic Bronchial Asthma associated with Functional Constipation)
HYPOTHESES Null Hypothesis (H0) Virechana Karma and Rasayana therapy has no efficacy in the management of Udavartajanya Santamaka Shwasa (Allergic Bronchial Asthma associated with Functional Constipation).
Alternate Hypothesis (H1) Virechana Karma and Rasayana therapy has efficacy in the management of Udavartajanya Santamaka Shwasa (Allergic Bronchial Asthma associated with Functional Constipation).
Brief Methodology: Clinical trial involving single group of 40 participants. Patients visiting the OPD of AIIA will be screened based on specific proforma and those who are eligible will be admitted to the Kayachikitsa IPD of AIIA. Patients will be given Deepana Pachana with Musta and Shunthi Churna, Snehapana with Kantakari Ghrita, Virechana with Trivritadi Yoga, followed by Rasayana therapy with Amalaki Rasayana.
PRIMARY OBJECTIVE To assess the changes in PFT parameters such as Forced Expiratory Volume in 1 second (FEV1), Forced Vital Capacity (FVC), ratio between FEV1 and FVC, and Peak Expiratory Flow Rate (PEFR) after Virechana Karma and Rasayana therapy in patients of Udavartajanya Santamaka Shwasa (Allergic Bronchial Asthma associated with Functional Constipation).
SECONDARY OBJECTIVES
To assess the effect of Virechana Karma and Rasayana therapy on the frequency, severity, and recurrence of cardinal symptoms of Santamaka Shwasa.
To evaluate the improvement in lung functions using validated scoring tools viz. mMRC Dyspnoea Scale and Asthma Control Questionnaire (ACQ).
To evaluate the improvement in bowel habits and related symptoms using standardized scoring systems (Patients Assessment of Constipation Symptoms Questionnaire Score and Wexner Constipation Scoring System).
To evaluate the efficacy of Virechana Karma and Rasayana therapy in the management of allergy.
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