| CTRI Number |
CTRI/2024/08/071937 [Registered on: 06/08/2024] Trial Registered Prospectively |
| Last Modified On: |
24/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical trial to study the effect of Ruchakadi
churna in malavibandha with special reference to functional
constipation between age 4 to 16 years. |
|
Scientific Title of Study
|
A randomised controlled clinical trial to study the effect of Ruchakadi Churna
In Malavibandha with special reference to functional constipation in children. |
| 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 Madhuri Bapusaheb Kadlag |
| Designation |
Post Graduate Student |
| Affiliation |
SMBT Ayurved College and Hospital |
| Address |
Department of Kaumarbhritya SMBT Ayurved College and Hospital Dhamangoan, Nashik.
Nashik
MAHARASHTRA
422403
India |
| Phone |
7507742492 |
| Fax |
|
| Email |
kadlagmadhuri2105@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jitesh Thakur |
| Designation |
Guide |
| Affiliation |
SMBT Ayurved College and Hospital |
| Address |
Department of Kaumarbhritya SMBT Ayurved College and Hospital Dhamangoan, Nashik.
Flat no-9, Vakratund heights, Nivruttinagar, opposite jatra hotel, Adgoan shivar, Nashik-422003
Nashik
MAHARASHTRA
422403
India |
| Phone |
8329041794 |
| Fax |
|
| Email |
thakurjiteshyadav@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhuri Bapusaheb Kadlag |
| Designation |
Post Graduate Student |
| Affiliation |
SMBT Ayurved College and Hospital |
| Address |
Department of Kaumarbhritya SMBT Ayurved College and Hospital Dhamangoan, Nashik.
MAHARASHTRA
422403
India |
| Phone |
7507742492 |
| Fax |
|
| Email |
kadlagmadhuri2105@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Kaumarbhritya SMBT Ayurved college and Hospital Dhamangoan Tal Igatpuri Dist.Nashik 422403 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Dr Madhuri Bapusaheb Kadlag |
| Address |
Department of Kaumarbhritya SMBT Ayurved college and hospital Dhamangoan,Tal Igatpuri, Dist. Nashik 422403, state Maharastra, India |
| Type of Sponsor |
Other [Self individual] |
|
|
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 Madhuri Bapusaheb Kadlag |
SMBT Ayurved College and Hospital |
OPD no 12 Department of Kaumarbhritya SMBT Ayurved College and hospital Dhamangoan Igatpuri Nashik.
Nashik
MAHARASHTRA |
7507742492
kadlagmadhuri2105@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMBT Ayurved college and Hospitlal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K590||Constipation. Ayurveda Condition: MALA-APRAVRUTIHĂ‚Â (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ruchakadi churna, Reference: Prof Ramanath Dwivedy, Chakkradatta Samhita with vaidyaprabha hindi commentary by Dr Indradeva Tripathi, Chapter no -26, shlok no- 67, Chaukhambha sanskrit Bhavan, Varanasi,page no- 179. , Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: yav kwath), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vaishwanar Churna, Reference: Shri Rajeshwardatta shastri ed, shri Brahmashankar Mishra, Shri Ambikadatta shastri, Bhaishajyaratnavali Vidyotini hindi commentry, Chapter no -29, shlok no-48-51,, chaukhamba prakashan, varansi,19 th edition, page no- 618., Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Ushnodak), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1.Children fulfilling ROME IV Criteria
(Must include 2 or more of the following
symptoms over preceding 3 months in a child with
developmental age is at least 4 years or above)
2.Fewer than 3 spontaneous bowel movements per
week.
3.Straining for more than 25 % of defecation
attempts.
4.Lumpy or hard stools for at least 25 % of
defecation attempts.
5.Sensation of anorectal obstruction or blockage
for at least 25 % of defecation attempts.
6.Sensation of incomplete defecation for at least
25 % of defecation
7.Manual maneuvering required to defecate for at
least 25 % of defecation attempts. |
|
| ExclusionCriteria |
| Details |
1.A patient having associated symptoms of other
systemic disease.
2.Hormonal diseases such as known case of
Hypothyroidism etc.
3.Drug induced.
4.Life threatening systemic infection like HIV.
5.Patient who needs to be hospitalized.
6.Patients who need to undergo surgery.
7.Patients with congenital anomalies that affect the anal area.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in delay or difficulty in defecation after giving Ruchakadi churna. |
14 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| comparison with trial and control groups. |
18 months |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
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)
|
15/08/2024 |
| 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 Yet Recruiting |
| 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
|
The prevalance of functional constipation is 14.4 percent. functional constipation is regarded as a distint condition and if not treated properly can lead to several disease. Ruchakadi churna have properties like deepan and pachan and having a snigdha guna which help in passing of stool and reduce the symptoms of constipation. Null Hypothesis Ruchakadi churna is not effective in Malavibandha (functional constipation) in children. Alternative Hypothesis Ruchakadi churna is effective in Malavibandha (functional constipation) in children. Conducting research to evaluate the effectiveness of Ruchakadi churna in treating functional constipation is crucial for expanding our understanding of traditional remedies and their applications in modern healthcare. By filling the knowledge gap, the study can provide valuable insights into the potential benefits of Ruchakadi Churna and its role in managing constipation. Including patient within the age group 4 years to 16 years who fulfill the clinical diagnostic criteria for functional constipation patients are selected irrespective of sex, socio-economic status and community helps in achieving a diverse and representative sample, written consent from parents ensures ethical compliance and transparency in the treatment process. SAMPLE SIZE using formula Daniel 1999 the calculated sample size is 47. Simple random sampling technique will be used. Total 94 numbers of patients will be selected and divided into two groups named as Gruop A (trial group) and Group B (Control group). Ruchakadi Churna Group A and Vaishvanar churna Group B will be given to patients.Trial and control drugs will be purchased from GMC certified pharmacy. Both drug will be administered in churna form for 7 days. All SOP of churna vidhi will be strictly followed during and after treatment. Observations will be done on Day 0, Day 7 and day 14. Result of the study will draw on basis of criteria of assessment and statistical analysis. Discussion will be done on the basis of observations and result obtained during the treatment. Summary will be drawn and whole thesis work will be summarized. Conclusion will be drawn strictly on basis of ststistical analysis and will be unbiased. |