| CTRI Number |
CTRI/2025/02/080371 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
03/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparative studty of Lajasattu
and lajasattu With Sheetali Pranayam in amlapitta (acidity) |
|
Scientific Title of Study
|
A Comparative Clinical studty of Lajasattu and Lajasattu With Sheetali Pranayam in Amlapitta |
| 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 laxmi patel |
| Designation |
PG Scholar |
| Affiliation |
Shri NPA govt ayurvedic college raipur |
| Address |
Department of Swasthavritta and Yoga
Shri Narayan prasad awasthi govt ayurved college raipur chhattisgarh
Raipur
CHHATTISGARH
492010
India |
| Phone |
7697687426 |
| Fax |
|
| Email |
laxmipatel307@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anita Sharma |
| Designation |
Professor Department of swasthavritta and yoga |
| Affiliation |
Shri Narayan Prasad Awasthi Government Ayurved College Raipur |
| Address |
Department of swasthavritta and yoga
Shri Narayan prasad awasthi govt ayurved college raipur chhattisgarh
Raipur
CHHATTISGARH
492010
India |
| Phone |
9827115211 |
| Fax |
|
| Email |
ansharma260@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sasmita Tripathy |
| Designation |
Reader department of swasthavritta and yoga |
| Affiliation |
Shri Narayan Prasad Awasthi govt ayurved college raipur Chhattisgarh |
| Address |
department of swasthavritta and yoga
shri narayan prasad awasthi govt ayurved college raipur chhattisgarh
Raipur
CHHATTISGARH
492010
India |
| Phone |
8763650383 |
| Fax |
|
| Email |
sasmita1980@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Swasthavritta and Yoga, Shri Narayan Prasad Awasthi Govt Ayurved College Raipur Chhattisagarh 492010 India |
|
|
Primary Sponsor
|
| Name |
Shri Narayan prasad awasthi govt ayurved college raipur chhattisgarh |
| Address |
shri Narayan prasad awasthi govt ayurved college raipur chhattisgarh 492010 India |
| Type of Sponsor |
Other [Shri Narayan prasad awasthi govt ayurved college raipur chhattisgarh 492010 India] |
|
|
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 Laxmi Patel |
Shri Khudadad Doongaji Government Ayurved Hospital Raipur Chhattisgarh |
OPD No.06 Swasthavritta and yoga OPD
Raipur
CHHATTISGARH |
7697687426
laxmipatel307@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE SHRI NARAYAN PRASAD AWASTHI GOVERNMENT AYURVED COLLEGE RAIPUR CHHATTISGARH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K219||Gastro-esophageal reflux disease without esophagitis. Ayurveda Condition: AMLAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Lajasattu, Reference: Bhaishjya Ratnavali Amlapitta Chikitsa Rogadhikar 56/05, Route: Oral, Dosage Form: Sattu, Dose: 30(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: water), Additional Information: - | | 2 | Comparator Arm | Procedure | - | Sheetali Pranayam | (Procedure Reference: Hathyog Pradipika 02/04, Procedure details: Firstly,sit in Sukhasana(a comfortable cross-legged position)Then ,take a deep breath in & exhale once,inhaling deeply through a curled tongue forms a tube shape, which cools the body by drawing in cool air. Then, exhaling slowly through the nose, as per capacity (two times per day) for 60 days.)
(1) Medicine Name: Lajasattu, Reference: Bhaishjya Ratnavali Amlapitta Chikitsa 56/5, Route: Oral, Dosage Form: Sattu, Dose: 30(g), Frequency: bd, Duration: 60 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.The patients with all general symptoms of Amlapitta according to Ayurvedic texts.
2.Patients between the age group of 18 to 60 years.
3.Chronicity less than 1 year.
4.Patients who give their consent in writing will be participating in this study. |
|
| ExclusionCriteria |
| Details |
1.Patients age group below 18 and above 60.
2.Patients Suffering from any Kaphaj vikar: like -Pratishyay.
3.Chronicity more than 1 year.
4.Gastric and Peptic ulcer.
5.Patients not willing to participate in a clinical Study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduces primary symptoms of amlapitta |
60 dayas |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
improve digestive function
improve the quality of life
|
60 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 2 |
|
Date of First Enrollment (India)
|
10/03/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Introduction: Ayurveda emphasizes preventive healthcare, promoting a balanced lifestyle and yoga for well-being. Amlapitta, It is not mentioned in Brihattrayi as a separate disease but the term Amlapitta has been mentioned at several places in Samhitas. is well-documented and linked to hyperacidity symptoms like indigestion and burning sensations. Definition: Amlapitta arises from imbalances in pitta dosha, often caused by irregular diet, stress, and poor lifestyle, leading to sourness, nausea, and digestive issues. Need for Study: Due to its increasing prevalence (7.6%-30% in India), especially with modern lifestyles, there is a need for natural, economical treatments like Lajasattu and Sheetali Pranayama. Aim and Objectives: The study aims to compare the effects of Lajasattu and its combination with Sheetali Pranayama on Amlapitta by assessing symptoms and their relief. Hypothesis: Lajasattu and Sheetali Pranayama are hypothesized to alleviate Amlapitta symptoms, supported by their cooling and pitta-pacifying properties. Study Design: Conducted at an Ayurvedic college hospital in Raipur, it involves 60 participants divided into two groups, treated over 60 days with regular follow-ups. Treatment Protocol: Group A receives Lajasattu (24g) with Sita Madhu (6g), and Group B adds Sheetali Pranayama to this regimen, focusing on its cooling and digestive benefits. Assessment: Key symptoms like nausea, burning, heaviness, and belching are scored before and after treatment for effectiveness evaluation. Pathya-Apathya: Diet and lifestyle modifications play a vital role in treatment, emphasizing light, cooling foods and avoiding irritants like alcohol and spicy food. Previous Research: Several studies validate the efficacy of Ayurvedic remedies like Lajasattu and yoga practices in treating hyperacidity. Significance: The study aligns with Ayurveda’s principles, offering accessible and cost-effective solutions to manage lifestyle diseases like Amlapitta. Statistical Analysis: Data will be analyzed using paired t-tests and other statistical tools to ensure objective evaluation. Yoga Modality: Sheetali Pranayama, known for its cooling effect, will be performed under expert guidance, complementing dietary treatment. Expected Outcome: The combination of Lajasattu and Sheetali Pranayama is anticipated to show significant improvement in Amlapitta symptoms. Conclusion: Findings will contribute to Ayurveda’s role in modern healthcare, promoting holistic and sustainable treatments for common ailments.
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