FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/04/041619 [Registered on: 04/04/2022] Trial Registered Prospectively
Last Modified On: 24/03/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Ashtaguna manda ka agnimandya me prabhav  
Scientific Title of Study   "A Clinical Study To Evaluate The Effect Of Ashtaguna Manda On Agnimandya" 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Deepika kunwar 
Designation  PG. Scholar 
Affiliation  Shri Narayan Prasad Awasthi Govt. Ayurveda College Raipur Chhattisgarh 492010 
Address  OPD No 06 Department of Swasthavritta And Yoga Shri Narayan Prasad Awasthi Govt. Ayurveda College Raipur Chhattisgarh 492010
Behind Gayatri Hospital Tarun Nagar Rohinipuram Danganiya Raipur Chhattisgarh 492010
Raipur
CHHATTISGARH
492010
India 
Phone  6260089589  
Fax    
Email  kunwardeepika38@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sasmita Tripathy 
Designation  Reader 
Affiliation  Shri Narayan Prasad Awasthi Govt. Ayurveda College Raipur Chhattisgarh 492010 
Address  OPD No 06 Department of Swasthavritta And Yoga Shri Narayan Prasad Awasthi Govt. Ayurveda College Raipur Chhattisgarh 492010
Govt. Ayurveda College Campus Raipur Chhattisgarh 492010
Raipur
CHHATTISGARH
492010
India 
Phone  8763650383  
Fax    
Email  sasmita1980@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anita Sharma 
Designation  Professor 
Affiliation  Shri Narayan Prasad Awasthi Govt. Ayurveda College Raipur Chhattisgarh 492010 
Address  OPD No 06 Department of Swasthavritta And Yoga Shri Narayan Prasad Awasthi Govt. Ayurveda College Raipur Chhattisgarh 492010
New Shanti Vihar Colony Near Swami Vivekananda School Gate No 01 Danganiya Raipur Chhattisgarh 492010
Raipur
CHHATTISGARH
492010
India 
Phone  9827115211  
Fax    
Email  ansharma260@gmail.com  
 
Source of Monetary or Material Support  
Department of Swasthavritta And Yoga Shri Narayan Prasad Awasthi Goverment Ayurved College Raipur Chhattisgarh 
 
Primary Sponsor  
Name  Department of Swasthavritta And Yoga 
Address  Department of Swasthavritta Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh  
Type of Sponsor  Government medical college 
 
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 
Deepika Kunwar  Shri Khhudadad Dungaji Government Ayurveda Hospital Raipur Chhattisgarh   OPD No 6 Department of Swasthavritta And Yoga Shri Khhudadad Dungaji Government Ayurveda Hospital Raipur Chhattisgarh 492010
Raipur
CHHATTISGARH 
6260089589

kunwardeepika38@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K30||Functional dyspepsia. Ayurveda Condition: Agnimandya,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Trikatu, Hingu, Dhaniya, Mudga, Reference: Sharangadhara Samhita, Route: Oral, Dosage Form: Dravaka, Dose: 80(ml), Frequency: sos, Bhaishajya Kal: Muhurmuhu, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: Manda Kalpana should be freshly prepared
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.the age group between the 18 to 60 years.
2. patients are selected irrespective of their gender, religion, occupation, marital status, socio-economic status etc.
3. on the basis of agnimandya criteria will be selected.  
 
ExclusionCriteria 
Details  1. the patients age group of exclusion was preferred as below 18 year and above 60 years will be excluded.
2. patients having any type of cancer especially associated with GI. tract pancreas and liver will be excluded from study. The agnimandya occur during renal failure, hepatitis, peptic ulcer, gastro-oesophageal reflex, acute gastritis, pregnant women will be excluded from the studying
3. patients suffering from any systemic diseases such as TB,HTN, etc.
4. patients not willing for the study.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Sign and symptoms of agnimandya is Aruchi, Ajeerna, Adhmana, Avipaka,Chardi,Vibandha,Abhyavaharna Sakti,Jarana Sakti, Malapravritti will be reduce.  First follow up after 7 days  
 
Secondary Outcome  
Outcome  TimePoints 
symptoms of agnimandya like 1.Ajeerna 2.Aruchi 3.Adhaman 3.Chardi 4.Jarana sakti 5.malapravrittti etc. will be reduce.  30 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   15/04/2022 
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   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

INTRODUCTION:-

The aim of Ayurveda is to promote and preserve health, strength and longevity of the healthy person and to cure the diseases. (1)

Aayu (Life-span), Varna (complexion), Bala (Strength), Swaasthya (health) Utsaaha (enthusiasm), Prabha (luster), (Oja) immunity, energy, heat processes and vital breath all these depend on Dehagani, one dies if this fire is extinguished, lives long free from disorders if it is functioning, properly. Gets ill if is deranged. Hence Agni is the root cause of all disease. (2)

Agnimandya is derived from two words Agni (Digestive juices), and Manda (Low), so the condition in which the food is not properly digested due to the diminished power of Jatharagni (Digestive Juices) is known as Agnimandya. In Ayurveda, Agnimandya is considered as principal cause for all metabolic disorders. Agnimandya can be due to irregular dietary habits, excessive intake of liquids. Avoidance of natural bowel reflex and habit of irregular sleep. Sometimes, Agnimandya is the symptoms of certain other diseases such as fever, anemia, diarrhoea, indigestion, etc. (3)

In present scenario diet is the major factor that influence health or diseases. The wholesome diet in diseased person is worth more hundred times than medicines and no medication can do well to a patient who does not observe a strict regimen for diet. It is possible to make a person disease free with intake of proper diet only. No medicine is equivalent to food hence it is considered as Mahabhaishaja by Acharya Kashyap. It reflects the Sidhant of “पथ्येसतिगदार्तस्यकिमौषधनिषेवणैः” of Acharya Lolimbraj. Acharya Charaka classified into twelve subdivisions of Ahara Dravya, like a set of cereal.

Krittanna Varga is one among them. It is a group consisting of food preparation such as Manda, Peya, Vilapi etc.Manda variety of Krittanna Varga is indicated as a

wholesome diet for a healthy or diseased person under Ayurvedic medications or during and after purificatory procedures. (4)

सिक्थकैःरहितो मण्डः।

1 part of Tandula +14 parts of water only. Supernatant liquid part is called as Manda (5)

NEED OF THE STUDY -

    Indigestion, also known as dyspepsia or upset stomach, is a condition of impaired digestion. Prevalence of dyspepsia is about 20-30% worldwide. A study from India reported prevalence of dyspepsia is about 20-30% (6)(7).

The life style of society has become very fast, sedentary and stressful which effects digestion. These conditions frequently leads people towards irregular and bad habits of Ahara and Vihara with the suppression of natural urges like Kshudha etc. and creating problems like Agnimandya, Aruchi. Due to decrease in intensity of Agni, the Apachit Ahar-rasa is produced leads to Strotorodha and Aama nirmiti. Hence while treating any disease the Sampraptibhanga always starts with Amapachana and Agnivardhana Chikitsa. (8)  

Manda Kalpana stimulates power of digestion and Vatanulomaka in nature. It softens the channels of circulation, stimulates perspiration. By virtue, the capacity to promote digestion, and Tridoshamaka.(9) 

 It is important to treat the disease in the initial stage to prevent Upadrava. It is helpful for both healthy and diseased individuals. Keeping all above in mind, this topic is selected for research.

 
Close