| CTRI Number |
CTRI/2025/08/092381 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
02/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Evaluate the role of chaturbeeja churna and Dashamularista in peurperialmanagement. |
|
Scientific Title of Study
|
To evaluate the efficacy of Chaturbeeja churna and Dashamularista in sutika paricharya a comparative study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Minuwara Khatun |
| Designation |
Pg scholar |
| Affiliation |
Govt Ayurvedic College and Hospital, Gauhati |
| Address |
Government ayurvedic college and Hospital, Guwahati 781014
Department of prasuti tantra and stree roga.
Ground floor, room no 10
Kamrup
ASSAM
781014
India |
| Phone |
9101122755 |
| Fax |
|
| Email |
minuwarakhatun070@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yanbeni Humtsoe |
| Designation |
Professor and HOD, Department of Prasuti Tantra Evum Stree Roga |
| Affiliation |
Government Ayurvedic College and Hospital, Jalukbari, Guwahati,Assam, 781014 |
| Address |
Government Ayurvedic College and Hospital, Jalukbari Guwahati,Assam,781014, Department of Prasuti Tantra Evum Stree Roga, Division ground floor, room no 10
Kamrup
ASSAM
781014
India |
| Phone |
9678686631 |
| Fax |
|
| Email |
pybeni17@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yanbeni Humtsoe |
| Designation |
Professor and HOD, Department of Prasuti Tantra Evum Stree Roga |
| Affiliation |
Government Ayurvedic College and Hospital, Jalukbari, Guwahati,Assam, 781014 |
| Address |
Government Ayurvedic College and Hospital, Jalukbari Guwahati,Assam,781014, Department of Prasuti Tantra Evum Stree Roga, Division ground floor, room no 10
Kamrup
ASSAM
781014
India |
| Phone |
9678686631 |
| Fax |
|
| Email |
pybeni17@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College and Hospital, Jalukbari, Guwahati, Assam, 781014 |
|
|
Primary Sponsor
|
| Name |
Minuwara Khatun |
| Address |
Government Ayurvedic College and Hospital, Guwahati, 781014 |
| 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 |
| Dr Yanbeni Humtsoe |
Government Ayurvedic College and Hospital, Jalukbari, Guwahati, Assam, 781014 |
Department of Prasuti Tantra Evum Stree Roga, ground floor division, Room no 10
Kamrup
ASSAM |
9678686631
pybeni17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, Government Ayurvedic College, Guwahati |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O909||Complication of the puerperium, unspecified. Ayurveda Condition: SUTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Chaturbeeja churna, Reference: Bhavaprakash nighantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Dashamoolarista, Reference: Sarangadhar samhita madhyam khanda, Route: Oral, Dosage Form: Arishta, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: - | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Chaturbeeja churna, Reference: Bhavaprakash nighantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: -(2) Medicine Name: Dasamoolarista, Reference: Sarangadhar samhita madhyam khanda, Route: Oral, Dosage Form: Arishta, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Sutika of age 20 to 45 years.
2.Spontaneous vaginal delivery. |
|
| ExclusionCriteria |
| Details |
1.Puerperial woman with history of LSCS.
2.Postpartum hemorrhage.
3.Systemic and infectious disorders.
4.Hb% below 8 grams. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Decrease in symptoms like
1.Purisha avarodh(constipation)
2.Nidrahani(insomnia)
3.katishool(backache)
4.parshwashool(pain in flanks)
5.angamarda(bodyache) |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Complete cessation of purisha avarodh and other associated symptoms like-
1.katishool(backache)
2.parshwashool(pain in flanks)
3.udarshool(pain in abdomen) |
45 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/09/2025 |
| 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
|
This is a comparative study to evaluate the clinical efficacy of Chaturbeeja churna with Dashamularishta in Sutika paricharya. Total 60 patients to be studied in 3 groups. In each group 20 patients will be selected. First group will be given Dashamularishta, second Chatubeeja churna and third group will be given both Chatubeeja churna and Dashamularishta for 45 days each. Patients will be followed up on 15th day till completion of treatment. |