| CTRI Number |
CTRI/2024/10/075774 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
11/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluate the efficacy of Abhayadi Leha in the management of Amlapitta(Hyperacidity). |
|
Scientific Title of Study
|
Randomized controlled clinical trial to evaluate the efficacy of Abhayadi Leha in the management of Amlapitta(Hyperacidity). |
| 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 Krushna Vijay Hamand |
| Designation |
Pg Scholar |
| Affiliation |
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya |
| Address |
Opd no 13, kayachikitsa department,C.S.M.S.S Ayurved mahavidyalaya and rugnalaya,Kanchanwadi,Aurangabad431011
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9404296247 |
| Fax |
|
| Email |
krushnahamand@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shrikant Gunwantrao Deshmukh |
| Designation |
Principal,Professor,H.O.D |
| Affiliation |
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya |
| Address |
OPD NO.13 Kayachikita Department C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya,kanchanwadi,Aurangabad
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9921553999 |
| Fax |
|
| Email |
dr.shrikantgdeshmukh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krushna Vijay Hamand |
| Designation |
Pg Scholar |
| Affiliation |
C.S.M.S.S Ayurved Mahavidyalaya |
| Address |
Opd no.13,Kayachiktsa department,C.S.M.S.S Ayurved mahavidyalaya and rugnalaya,Kanchanwadi,Aurangabad,431011
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9404296247 |
| Fax |
|
| Email |
krushnahamand@gmail.com |
|
|
Source of Monetary or Material Support
|
| C.S.M.S.S Ayurved mahavidyalaya and rugnalaya,Kanchanwadi,Aurangabad,Maharashtra,431011. |
|
|
Primary Sponsor
|
| Name |
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya |
| Address |
Kanchanwadi,Aurangabad,Maharashtra,India 431011 |
| Type of Sponsor |
Private 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 |
| Dr Krushna Vijay Hamand |
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya,Kanchanwadi |
OPD NO.13 Kayachikitsa department,C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya,Kanchanwadi,Aurangabad 431011
Aurangabad
MAHARASHTRA |
9404296247
krushnahamand@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Aurangabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K00-K95||Diseases of the digestive system. Ayurveda Condition: AMLAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Abhayadi Leha, Reference: Bharat bhaishayajya ratnakar, Part1/142, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: no | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Avipattikar churna, Reference: Ashtang hriday kalp sthan 2/21-23, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: Sheetal jala), Additional Information: no |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1) Gender - Male / Female.
2) Age - 20 years to 45 years.
3) Patient having clinical signs and symptoms of Amlapitta as described in Madhava Nidan. Ref. (Madhav Nidan 34/2,3)(20)
• Avipaka (Suffering from Indigestion)
• Klama (Fatigue)
• Utklesh(Nausea)
• Tikta Udgar (Bitter belching)
• Amla Udgar (Sour belching)
• Hruddah (Heartburn)
• Kanthadaha (Burning sensation in throat)
• Aruchi (Disliking of food)
4) Chronicity less than 1 year.
|
|
| ExclusionCriteria |
| Details |
1. Patients with diagnosed cases of gastric, peptic and duodenal ulcers.
2. Patients with any GIT, abdominal complications and chronic illness.
3. Patients with diagnosed cases of any systemic disorder.
4. Pregnant and lactating women.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Avipaka (Suffering from Indigestion) Klama (Fatigue) Utklesh(Nausea) Tikta Udgar (Bitter belching) this Lakshanas wi
ll be decreased. |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Amla Udgar (Sour belching) Hruddah (Heartburn) Kanthadaha (Burning sensation in throat) Aruchi (Disliking of food) this Lakshanas will be decreased.
|
14 Days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
24/10/2024 |
| 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
|
Amlapitta has become one of the common problem in present era due to change in lifestyle. It is a pitta dosha dushti disease of the Annavaha strotas (Digestive System) caused due to mandagni (Poor Apetite) and Ama. Amlapitta is mentioned by laghutrayee. At around 700 A.D Madhavakar describes amlapitta vyadhi separately in Madhavnidan. Amlapitta also mentioned by Yogaratnakar, Bhaishjyaratnavali, Rasaratnasamuchhaya etc. According to Charak Samhita in Grahani Adhyaya (Cholitis Chapter) finds similar and identical symptoms of Amlapitta in the purva rupa (Pre Symptoms) named under the term Shukta paka. Amlapitta may be caused due to excessive intake of oily, spicy, tinned, frozen, half cooked food, fast food, irregular meal patterns, habits like alcohol, smoking and psychological stress. i.e. Hurry, Worry and Curry have to avoid. Vitiation of agni is the main pathophysiological factor in all diseases. Amlapitta is the disease describe thoroughly by Madhava. Amlapitta caused due to mandagni the ingested food undergoes Vidagadpaka, & then the pachaka pitta attains excessive amlata & causes vidaha.
Due to urbanization, changed lifestyle and dietary incompatibility Amlapitta has became a common problem in the society..The prevalence of rate of Amlapitta is observed about 32%. It affects the quality of life and sometime though it is not life hindering but still it affects ones day to day life. Many studies have been done in this context but still it is a common prevalent problem. Many of individuals are suffering from Amlapitta. To avoid further complications, Amlapitta have to treat in early stages. Almost all available antacid drugs are liable to have side effects on body. Null Hypothesis :There is no significant role of ABHAYADI LEHA in management of Amlapitta. Alternative Hypothesis : There is significant role of ABHAYADI LEHA in management of Amlapitta.
The study will be conducted on 100 patients with 50 patients of trial group will be treated with Abhayadi leha and the other 50 patients of Control group will be treated with Avipattikar Churna and the result will be conducted. |