| CTRI Number |
CTRI/2024/09/074254 [Registered on: 24/09/2024] Trial Registered Prospectively |
| Last Modified On: |
20/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Pathadi churna in kaphaja pravahika (Amoebic Dysentery) |
|
Scientific Title of Study
|
Randomized controlled clinical study to evaluate the efficacy of pathadi churna in kaphaja pravahika with special reference to Amoebic dysentery. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd Supriya Dada Divate |
| Designation |
MD Scholar Kaumarbhritya |
| Affiliation |
CSMSS Ayurved Mahavidyalaya Kanchanwadi, Chh Sambhaji Nagar |
| Address |
Room no.14,Balroga OPD,CSMSSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi ,Aurangabad,India
Aurangabad
MAHARASHTRA
431002
India |
| Phone |
9890865936 |
| Fax |
|
| Email |
supriyadivate21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd K S Ratnaparkhi |
| Designation |
HOD and Professor |
| Affiliation |
CSMSS Ayurved Mahavidyalaya Kanchanwadi, Chh Sambhaji Nagar |
| Address |
Room no.14,Balroga OPD,CSMSSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi ,Aurangabad,India
Aurangabad
MAHARASHTRA
431002
India |
| Phone |
9421771722 |
| Fax |
|
| Email |
karunaratnaparkhi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd K S Ratnaparkhi |
| Designation |
HOD and Professor |
| Affiliation |
CSMSS Ayurved Mahavidyalaya Kanchanwadi, Chh Sambhaji Nagar |
| Address |
Room no.14,Balroga OPD,CSMSSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi ,Aurangabad,India
Aurangabad
MAHARASHTRA
431002
India |
| Phone |
9421771722 |
| Fax |
|
| Email |
karunaratnaparkhi@gmail.com |
|
|
Source of Monetary or Material Support
|
| CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi ,Aurangabad,Maharashtra ,India ,pincode-431002 |
|
|
Primary Sponsor
|
| Name |
Vd Supriya Dada Divate |
| Address |
CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi,Aurangabad ,Maharashtra,India ,pincode-431002
|
| Type of Sponsor |
Other [Self] |
|
|
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 |
| DrSupriya Dada Divate |
CSMSS Ayurved Mahavidyalaya and Rugnalaya |
Room no.14,Balroga OPD ,CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi ,Aurangabad India ,pincode-431002
Aurangabad
MAHARASHTRA |
9890865936
supriyadivate21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K638||Other specified diseases of intestine. Ayurveda Condition: PRAVAHIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Bilva Churna , Reference: Charak samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -Koshnajala), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Pathadi churna, Reference: Sushrut uttartantra 40/154, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: Koshnajala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed patient with classical signs and symptoms of Kaphaja pravahika -like Muhurmuhu mala pravrutti (Frequent defecation), Mala Pravahan (Straining to defecate ), Sashoola Mala (Colic pain during defecation, Sapiccha Mala (Mucous in stool) |
|
| ExclusionCriteria |
| Details |
Patients with the upadravas of Pravahika.
All other types of Pravahika except Kaphaja.
Other Protozoal infections
Patients with other infectious, metabolic diseases, congenital anomalies, and other systemic disorders. |
|
|
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
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Straining to defecate decreased.
Frequency of stool decreased.
Colic pain during defecation subsided.
|
Baseline 1st day,5th day ,9th day,14 th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mucous/Cyst/Trophozoite in Stool |
Baseline 1st,5th,9th,14 th |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 3 |
|
Date of First Enrollment (India)
|
02/10/2024 |
| 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
|
Ayurveda is an immense science which has been described in eight branches, kaumarbhritya is one of them which mainly deals with health & health related ailments of children . The disease in which pravahan occurs is called Pravahika. The disease Pravahika is a Swatantra Vyadhi as well as an Upadrava of Atisara. Susruta and Madhavakara first identified Pravahika as a distinctive disease and Charaka[7] mentions it as a symptom in Kaphaja Atisara and as a Basti Vyapat. Vagbhata has also explained about Bimbishi, which is a synonym of Pravahika. In Atisara, Nanavidha Dhatusaranam is present but in Pravahika there is a large amount of mucous with stool. Due to Nidana sevana, Vata gets vitiated resulting in a discharge of stools frequently with Kapha. After Pripakkva Ama Dosha, the patient passes liquid or hard stool. Mala Pravahan(Tenesmus), Sashoola Mala (Painful defecation) Sapiccha Mala (Mucous in stool), Alpaalpa Mala ( Minimal Stool defecation ), Bahusha(Frequent stool).
RATIONAL OF STUDY:
In the present era, the world is looking at Ayurveda with the hope that it is going to provide good assets for the treatment of ailing humanity are described in the management. In modern medicine, drugs may have side effects in a few individuals, so it has some limitations. In Ayurveda Acharya mentioned various dravyas that are effective as well as affordable for Pravahika patients, among those Pathadi Churna is selected. |