| CTRI Number |
CTRI/2022/05/042937 [Registered on: 31/05/2022] Trial Registered Prospectively |
| Last Modified On: |
28/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study of efficacy of Haritaki for metabolic transformation of byproduct generated due to improper or incomplete digestion |
|
Scientific Title of Study
|
Clinical study of efficacy of Haritaki (Terminalia chebula) for ama pachana. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amruta Sambhaji Atkare |
| Designation |
MD Scholar Samhita and Siddhant |
| Affiliation |
Ashtang Ayurved Mahavidyalaya, Pune. |
| Address |
Department of Samhita and Siddhant, 2nd floor, Ashtang Ayurved Mahavidyalaya, 2062 Sadashiv Peth, Vijaya Nagar Colony, Sane Guruji Road, Pune.411030
Pune
MAHARASHTRA
413002
India |
| Phone |
9403755800 |
| Fax |
|
| Email |
asa.amrutaatkare@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Bhandare |
| Designation |
Associate Professor, HOD of Ayurveda Samhita and Siddhant department |
| Affiliation |
Ashtang Ayurved Mahavidyalaya, Pune |
| Address |
2062 Sadashiv Peth, Vijaya Nagar Colony, Sane Guruji Road, Pune
Pune
MAHARASHTRA
411030
India |
| Phone |
9422080246 |
| Fax |
|
| Email |
drvijaybhandare@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amruta sambhaji Atkare |
| Designation |
PG scholar |
| Affiliation |
Ashtang Ayurved Mahavidyalaya, Pune |
| Address |
2062 Sadashiv Peth, Vijaya Nagar Colony, Sane Guruji Road, Pune
Pune
MAHARASHTRA
411004
India |
| Phone |
9403755800 |
| Fax |
|
| Email |
asa.amrutaatkare@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Ayurveda Samhita and Siddhant, Ashtang Ayurved Mahavidyalaya, Pune. |
|
|
Primary Sponsor
|
| Name |
Ashtang Ayurved Hospital Pune |
| Address |
2062 Sadashiv Peth, Vijaya Nagar Colony, Sane Guruji Road, Pune |
| 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 Amruta Sambhaji Atkare |
Ashtang Ayurved Hospital, Pune |
OPD no.3, kayachikitsa department, Ashtang Ayurved Hospital, 2062 Sadashiv peth, Vijaya Nagar Colony, Sane Guruji Road, Pune. 411030
Pune
MAHARASHTRA |
9403755800
asa.amrutaatkare@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K928||Other specified diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Haritaki (Terminalia chebula), Reference: Ashtang Hridaya, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Madhyabhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -Hot water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Subjects having symptoms of ama as mentioned in Ashtang Hridaya i.e. srtorodha, balabhransha, gaurav, anilmoodhata, alasya, apakti, nishthiva, malasanga, aruchi, klama. |
|
| ExclusionCriteria |
| Details |
1)Subjects with known case of chronic systemic diseases (like diabetes, hypertension etc.)
2) Subjects with Secondary emaciation (known case of prolonged infection)
3) Subjects with pregnancy or lactation
4) Subjects with immunocompromised diseases (such as AIDS, cancer etc.) |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Haritaki is effective when given with hot water at madhyabhakta Kala in 3gm quantity twice a day. |
After 15 days follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
01/06/2022 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This is clinical study based on ancient knowledge of Ayurveda. According to Ayurveda, ama is the main cause of many diseases, hence treatment of ama is the priority and pachana is one of the important aspect in the treatment of ama. For pachana of ama, Haritaki is given with the reference of Ashtang Hridaya. In this project Haritaki is given in powder form in 3gm quantity with hot water in the middle of meal twice a day for 15 days. Pachana of ama will be beneficial for treatment of many diseases. |