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CTRI Number  CTRI/2025/02/080595 [Registered on: 14/02/2025] Trial Registered Prospectively
Last Modified On: 30/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the effect of kushmanda swarasa and kapittha swarasa in gastritis 
Scientific Title of Study   An open label randomized control clinical study to evaluate the effect of kushmanda swarasa and kapittha swarasa as pathya 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 Tejaswini R 
Designation  PG Scholar 
Affiliation  JSS Ayurveda medical college and hospital, Mysuru 
Address  Department of PG studies in Swasthavritta, JSS Ayurveda medical college and hospital, Lalithadripura road, Mysuru

Mysore
KARNATAKA
570028
India 
Phone  9148611565  
Fax    
Email  tejaswiniramesh1829@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shalini S 
Designation  Associate Professor 
Affiliation  JSS Ayurveda medical college and hospital, Mysuru 
Address  Department of PG studies in Swasthavritta, JSS Ayurveda medical college and hospital, Lalithadripura road, Mysuru

Mysore
KARNATAKA
570028
India 
Phone  9886600552  
Fax    
Email  shalini6771@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shalini S 
Designation  Associate Professor 
Affiliation  JSS Ayurveda medical college and hospital, Mysuru 
Address  Department of PG studies in Swasthavritta, JSS Ayurveda medical college and hospital, Lalithadripura road, Mysuru


KARNATAKA
570028
India 
Phone  9886600552  
Fax    
Email  shalini6771@gmail.com  
 
Source of Monetary or Material Support  
JSS Ayurveda Medical College and Hospital, Lalithadripura road, Mysuru, Karnataka, India, 570028 
 
Primary Sponsor  
Name  Dr Tejaswini R 
Address  Department of PG studies in swasthavritta, JSS Ayurveda medical college and hospital, Lalithadripura road, Mysuru, Karnataka, India, 570028 
Type of Sponsor  Other [self] 
 
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 Tejaswini R  JSS Ayurveda medical college and hospital  Room no.12, Department of PG studies in Swasthavritta OPD, JSS Ayurveda medical college and hospital, Lalithadripura road, Mysuru
Mysore
KARNATAKA 
9148611565

tejaswiniramesh1829@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JSS Ayurveda medical college and hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K297||Gastritis, unspecified. Ayurveda Condition: AMLAPITTAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Kushmanda Swarasa, Reference: Bhaishajya ratnavali, Route: Oral, Dosage Form: Swaras/ Juice, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Kapittha swarasa, Reference: Bhaishajya ratnavali, Route: Oral, Dosage Form: Swaras/ Juice, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Subjects fulfilling the diagnostic criteria of Amlapitta, Subjects who are willing to participate in the study.  
 
ExclusionCriteria 
Details  Known case of gastric and duodenal ulcers, Subjects who have undergone gastric surgery, Gastritis which interfere with the treatment, Subjects with gastric malignancies.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Relived from symptoms of amlapitta  4 week 
 
Secondary Outcome  
Outcome  TimePoints 
No recurrence of symptoms of amlapitta  60th day 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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   N/A 
Date of First Enrollment (India)   03/03/2025 
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="6"
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  

NEED FOR STUDY

In this developing era, due to mechanical lifestyle, people are practicing poor and inappropriate dietary habits with processed food resulting in Agnimandhya and Ama which combines with Pitta cause inflammation to the gastric mucosa leading to Amlapitta. This is a common Annavaha SrotoDushti Vikara, also known as Hyperacidity, is a set of symptoms caused by an imbalance between the acid secreting mechanism of stomach and proximal intestine and the protective mechanisms that ensure their safety. The stomach normally secretes acids essential in the digestive process, excess production of which results in Hyperacidity. About 32% of adults aged 30-44 years have reported having acidity and indigestion problem by survey conducted in India in 2021.

Prolonged use of antacid to manage hyperacidity, leads to inhibition of absorption of Iron,      Calcium, and Phosphates, Milk-Alkali Syndrome, Impotency, Gynecomastia, Liver Damage, increase risk of Cancer.  Ayurveda emphasizes basic dietary guidelines in prevention and management of disease. The Ahara which are congenial to channels, constitution and strength of individual is Pathya Ahara. The impact of Amlapitta on Annavaha srotas is direct and is a psychosomatic disorder and dietary indiscretion plays significant roles. Ahara Dravyas as Amlapitta Pathya have been mentioned in Bhaishajya Ratnavali which are Purana shali, Yava, Mudga, Tapta Sheeta jala, Karavellaka, Patola leaves, Saktu, Kapittha  Kushmanda and Dadima.  There is a need of Pathya Ahara for excess use of antacids, hence with this background the present study will be conducted to know the efficacy of Kushmanda Swarasa and Kapittha  Swarasa as Pathya in Amlapitta .

REVIEW OF LITERATURE

·       According to ShabdhakalpadhrumaAhara is the substance which is ingested which includes food and drinks.

·       According to Charaka Samhitha– Food is the vital breath of living beings (that is why) the people rush to the food. Complexion, cheerfulness, good voice, life imagination, happiness, contentment, corpulence, strength, and intellect, all these are dependent on food.

·       According to Charaka SamhithaPathya is that which is not harmful to the paths (of the body) and is according to liking.

·       According to Gangadhara– The drugs and regimen which do not adversely affect the mind are considered as Pathya. Also, that which is wholesome to channels of the body or Srotases is called Pathya.

·       The word Amlapitta is composed of 2 words Amla +Pitta – Amlapitta.

·       Amlapitta is one of the common problems of Annavaha Srotas.

·       According to Madhava nidhana etiology. The pitta which has already accumulated in body gets further aggravated by consuming incompatible food combination, putrefied foods, sour foods, over burnt foods and pitta aggravating foods and drinks and is called Amlapitta.

·       In Amlapitta (Hyperacidity), the Quantity of Pachaka Pitta gets increased and it changes from normal bitter taste to sour taste.

·       In Madhukosha -The increase of Vidagda (burnt away) pitta is Amlapitta and that Vidagdha pitta undergoes fermentation and becomes sour (amlibhava) and causes Amlapitta.

·       According to Bhaishajya Ratnavali- One can include Kapittha and Kushmanda in their diet.

·       Kapittha- Limonia accidissima. This belongs to Rutaceae family, is a small deciduous glabrous    tree or medium sized tree up to 30 meter tall, armed with strong straight axillary thorns. Seed many, not be covered by mucilage, embedded in sour, tasty, fleshy, pulp fruits globose grey, rough, 2-3 inch diameter, rind hard, woody, fruit pulp edible. It is having Madhura-Amla rasa, Laghu-Ruksha Guna , Sheetha Virya and Katu Vipaka. It has TridoshaharaVatapitta Shamaka activity. Useful part fruit, leaves, flowers, bark, root and gum.

·       KushmandaBenincasa hispida. Which belongs to Curcurbiraceae family, is an annual branched climbers, extensive, trailing or climbing herb. Fruits fleshy, hairy when young, waxy bloom when mature, fruits broadly cylindrical or spherical gourd, 1-1.5 ft. long with white flesh, containing numerous, much compressed and marginal seeds. It is having Madhura rasa, Laghu-Snigdha Guna, Sheetha Virya, Madhura Vipaka. It has Vatapitta Shamaka, Sarvadoshahara (pakva fruit).


6.3  AIMS & OBJECTIVE OF THE STUDY

 

1.     To evaluate the effect of Kushmanda Swarasa (Benincasa hispida) in Subjects of Amlapitta as Pathya .

2.     To evaluate the effect of Kapittha Swarasa (Limonia  accidissima) in Subjects of Amlapitta as Pathya .

3.     To compare the effect of Kushmanda Swarasa (Benincasa hispida) and Kapittha Swarasa (Limonia  accidissima) in Subjects of Amlapitta as Pathya .

A.  Diagnostic criteria:

         Subject will be selected with cardinal features of Amlapitta like Hrit Kanta  daha, Tiktha Amlodhgara,  Klama, Utklesha, Avipaka, along with or without the following symptoms of Urdhwa and Adhoga Amlapitta .

             Chardi .

             Aruchi .

            Shiroruja.

          Vibandha.

          Adhmana

A. Assessment criteria:

Assessment is done on subjects based on below parameters.

        Hrit Kanta  daha .

        Tiktha amlodhgara.

        Klama .

        Utklesha.

         Avipaka.

        Chardi .

        Aruchi.

        Shiroruja.

        Vibandha.

Adhmana

        Plan of treatment:

            After taking informed consent 50 subjects will be assigned into Group A and Group B.

       GROUP A

 

        Sample size – 25 subjects.

        Procedure – Subjects will be Administered Kapittha swarasa (Limonia accidissima) 25ml twice daily before food for 30 days.   

         GROUP B

        Sample size – 25 subjects.

        Procedure – Subjects will be Administered Kushmanda swarasa (Benincasa hispida) 25ml  twice daily before food for 30 days

         Method of preparation of Kushmanda swarasa(Benincasa hispida)  -

Procedure – Fresh fruit of Kushmanda (Benincasa hispida)  will be  taken cut into small pieces , the kalka is made and blend, swarasa is extracted .

       Method of preparation of Kapittha swarasa(Limonia accidissima)

Procedure – Fresh fruit of Kapittha (Limonia accidissima) is taken, the pulp is scrapped and kalka is made and blend, swarasa is extracted.

 
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