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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:K30||Functional dyspepsia. Ayurveda Condition: Agnimandya, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Classical | | (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 “पथà¥à¤¯à¥‡à¤¸à¤¤à¤¿à¤—दारà¥à¤¤à¤¸à¥à¤¯à¤•िमौषधनिषेवणैः†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)
सिकà¥à¤¥à¤•ैःरहितो मणà¥à¤¡à¤ƒà¥¤
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. |