| CTRI Number |
CTRI/2025/09/094195 [Registered on: 03/09/2025] Trial Registered Prospectively |
| Last Modified On: |
03/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to find effects of Kola Amalaki powder with madhu in management of emesis gravidarum with special reference to modern aspect |
|
Scientific Title of Study
|
Randomized Controlled Clinical Trial To Determine The Effect Of Kola-Amalaki Churna With Madhu In The Management Of Garbhini Chhardi W.S.R To Emesis Gravidarum |
| 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 Sabrin Ismail Momin |
| Designation |
PG Scholar |
| Affiliation |
Sangam Sevabhavi Trust Ayurved Medical College Sangmner |
| Address |
Dept. of Prasuti Tantra and Stri Roga. SST Ayurved Medical college Sangamner Dist Ahmadnagar Maharashtra 422605 India Maharashtra 422605 India
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9527143286 |
| Fax |
|
| Email |
Sabrinmomin777@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Shinde |
| Designation |
HOD Dept. of Prasuti Tantra and Stri Roga |
| Affiliation |
Sangam Sevabhavi Trust Ayurved Medical College Sangmner |
| Address |
Dept. of Prasuti Tantra and Stri Roga. SST Ayurved Medical college Sangamner Dist Ahmadnagar Maharashtra 422605 India Maharashtra 422605 India
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9881303593 |
| Fax |
|
| Email |
amitshinde112@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Shinde |
| Designation |
HOD Dept. of Prasuti Tantra and Stri Roga |
| Affiliation |
Sangam Sevabhavi Trust Ayurved Medical College Sangmner |
| Address |
Dept. of Prasuti Tantra and Stri Roga. SST Ayurved Medical college Sangamner Dist Ahmadnagar Maharashtra 422605 India Maharashtra 422605 India
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9881303593 |
| Fax |
|
| Email |
amitshinde112@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sangam Sevabhavi Trust Ayuvrved Medical College Sangamner Dist Ahmadnagar India 422605
|
|
|
Primary Sponsor
|
| Name |
Dr Sabrin Ismail Momin |
| Address |
Sangam Sevabhavi trust Ayurved mahavidyalay Sangamner ghulewadi dist Ahmadnagar 422605
|
| Type of Sponsor |
Other [Own Research Study] |
|
|
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 Sabrin Ismail Momin |
Sangam Seva Bhavi Trust Ayurved Mahavidyalay Sangamner |
OPD Divison, 1st Floor, Room No 1, Stree Rog Avum Prasutitantra OPD, Ahmednagar Maharashtra
Ahmadnagar
MAHARASHTRA |
9527143286
Sabrinmomin777@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee SSTAC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O210||Mild hyperemesis gravidarum. Ayurveda Condition: DAUHRUDAJA-CARDIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: KOLA-AMALAKI, Reference: SUSHRUT UTTARTANTRA 49/33, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2.5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Yashtimadhu, Reference: Bhavprakash Puravakhand Haritkyaadivarga, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2.5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Pregnant women of 21 to 35 yr, irrespective of her parity carring viable
intrauterine pregnancy who will ready to give informed written consent.
2. Pregnant women having complaints of frequent vomiting, Hrillas (Nausea),
Annadwesha (Anorexia)
3. Pregnant women within 12 weeks of viable intrauterine gestation. |
|
| ExclusionCriteria |
| Details |
1. Known pregnant women with Hyperemesis Gravidarum.
2. Known Pregnant women with dehydration due to vomiting
3. Known pregnant women with major medical or obstetrics illness or major
systemic diseases like Cardio Vascular Disease, Cancer, Asthama,
Tuberculosis, HTN, DM. etc.
4. Known Pregnant women with molar pregnancy.
5. Bad obstetric history (BOH)
6. Pregnant women having Ectopic pregnancy
7. Known pregnant women with k/c/o Convulsive disorder, Fetal Anamolis.
8. Known pregnant women suffering from communicable diseases.
9. High risk pregnancy like a Elderly Primigravida, PIH, PV bleeding |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Appetite, Nutritions and Patient can do day today activites easily |
4 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to observe & documnet the effect of kola-amalaki churna with madhu in the manegemnet of garbhini chhhardi w.s.r. emesis gravidarum |
4 Weeks |
|
|
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 2 |
|
Date of First Enrollment (India)
|
02/10/2025 |
| 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 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
|
Garbhini Chhardi affects the quality of life of pregnant woman and pregnancy out comes. In unresponsive cases needs hospitalization and even termination of pregnancy. The clinical management of disease as per modern drugs advice antiemetics which have notorious adverse effects. Long term use of anti-emetic drugs have linked to a number of congenital defects and malformation. This study is important in view of enhancing the scope of Ayurvedic treatment of pregnant women suffering from Chhardi. Ayurvedic antiemetic preparations are very gentle and potent. They can be used for long term treatment without any harm to the fetus. Kola-Amalaki Churna is light to digest, Sheet Virya, Balya and possess chhardighna properties. Badara (Zizyphus jujuba) is Madhura, Amla, Kashaya, Sheeta Virya, Madhura Vipaka and Vata Pitta Samaka properties mentioned In Chhardighna Mahakashaya by Acharya Charaka Amalaki is Pancharasa, Sheet Virya Dipana, Pachana properties and Rasayana drug Amalaki Phala Majja has the property of chhardighna and Vatnashaka. this study will be helpful to provide safe life and better result for pregnant women suffering from Garbhini Chhardi. Hence study is planned as “Randomized controlled clinical trial to determine the effect of Kola-Amalaki Churna with Madhu in the management of Garbhini Chhardi W.S.R. To Emesis Gravidarum.”
|
|