| CTRI Number |
CTRI/2025/06/089581 [Registered on: 25/06/2025] Trial Registered Prospectively |
| Last Modified On: |
07/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluate the Efficacy of Atrushak Gel and Atrushak Sidh Tail on Labour. |
|
Scientific Title of Study
|
A Comparative Clinical Study to Evaluate the Efficacy of Atrushak Gel and Atrushak Sidh Tail on Prasav. |
| 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 Charu Lata |
| Designation |
Sr. Lecturer |
| Affiliation |
Rajiv Gandhi Government Post Graduate College And Hospital,Paprola Kangra,Himachal Pradesh |
| Address |
Room no. 204 PG department of Prasuti tantra evam stree roga Rajiv Gandhi Government Post Graduate College And Hospital,Paprola
Kangra,Himachal Pradesh
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
08411840183 |
| Fax |
|
| Email |
charugupta_sol@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Charu Lata |
| Designation |
Sr. Lecturer |
| Affiliation |
Rajiv Gandhi Government Post Graduate College And Hospital,Paprola Kangra,Himachal Pradesh |
| Address |
Room no. 204 PG department of Prasuti tantra evam stree roga Rajiv Gandhi Government Post Graduate College And Hospital,Paprola
Kangra,Himachal Pradesh
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
08411840183 |
| Fax |
|
| Email |
charugupta_sol@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr. AKANKSHA |
| Designation |
PG Scholar, Prasuti Tantra evum Stree Roga |
| Affiliation |
Rajiv Gandhi Government Post Graduate College And Hospital,Paprola Kangra,Himachal Pradesh |
| Address |
Room no. 804 PG department of Prasuti tantra evam stree roga Rajiv Gandhi Government Post Graduate College And Hospital,Paprola
Kangra
HIMACHAL PRADESH
175015
India |
| Phone |
7503383887 |
| Fax |
|
| Email |
akanksha.anku3007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak pharmacy,Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital,Paprola,Distt Kangra,HP,Research Institute in ISM Joginder Nagar,Distt-Mandi,HP |
|
|
Primary Sponsor
|
| Name |
Prof Vijay Chaudhary |
| Address |
Principal cum Dean Room no.105 Admin Block Rajiv Gandhi Government Post Graduate Ayurvedic College Paprola,District Kangra ,HP |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| HOD Deptt of Prasuti Tantra evum Stree Roga |
Rajiv Gandhi Government Post Graduate Ayurvedic College Paprola,District Kangra ,HP |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Charu Lata |
Rajiv Gandhi Government Post Graduate College And Hospital,Paprola Kangra,Himachal Pradesh |
OPD 210 & IPD 800 Department of Prasuti Tantra evum Stree Roga, Rajiv Gandhi Government Post Graduate College And Hospital
Kangra
HIMACHAL PRADESH |
08411840183
charugupta_sol@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(Human),RGGPG Ayurvedic College and Hospital ,Paprola Distt. Kangra , HP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O80||Encounter for full-term uncomplicated delivery. Ayurveda Condition: ASANNAPRASAVAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: aatruhsak gel, Reference: NA, Route: Vaginal, Dosage Form: Kalka/ Paste, Dose: 5(g), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 10 Days, Reference: NA, Route: , Dosage Form: Kalka/ Paste, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (3) Medicine Name: 10 Days, Reference: NA, Route: , Dosage Form: Kalka/ Paste, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Atrushaka sidh tail, Reference: NA, Route: Vaginal, Dosage Form: Taila, Dose: 5(g), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 10 Days, Reference: NA, Route: NA, Dosage Form: Taila, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Subject (Pregnant women) willing for trial.
2.Primigravida with 37 weeks of gestational age and onwards.
3.Subject (Pregnant women) having haematological /routine ANC investigations within normal limits.
4.Pregnant women having gynaecoid pelvis, border line pelvis and cephalic presentation. |
|
| ExclusionCriteria |
| Details |
1.Pregnant women not willing for the trial.
2.Multipara
3.CPD
4.APH
5.Pregnancy induced hypertension.
6.IUD
7.IUGR
8.Subject (Pregnant women) having Hb less than 8 gm%.
9.Uterine malformations
10.Gestational diabetes |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Effect of Atrushak Sidha gel & Atrushak sidh tail on Progress of labour.
2.Relief in associated problems related to maternal pregnancy |
Outcome will be assessed in 10 days from onset of trial |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Effect of Atrushak Sidha gel & Atrushak sidh tail on Progress of labour.
2.Relief in associated problems related to maternal pregnancy |
10 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
25/06/2025 |
| 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="0"
Months="4"
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
|
Research report will be soon published after the completion of the trial of the 60 patients fulfilling the inclusion and exclusion criterias will be randomly selected from the OPD and IPD of the department pf Prasuti Trantra evam Stree Roga. RGGPG Ayurvedic College and Hospital,Paprola, Distt. Kangra,HP. Patients will be divided into two groups of 15 each.
1.Use of Aatrushak gel;ROUTE:Intravaginally(Yonilepa);DOSE:5 ml 2.Use of Aatrushak sidh tail;ROUTE:Intravaginally;DOSE:5 ml
DURATION OF CLINICAL TRIAL:at or after 37 weeks of gestational age for consecutive 10 days.
Result will be assesssed on the basis of Objective assessement criterias. |