| CTRI Number |
CTRI/2024/07/071531 [Registered on: 30/07/2024] Trial Registered Prospectively |
| Last Modified On: |
25/07/2024 |
| 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
|
Effect of hingvadi churna in post delivery backache: A clinical study |
|
Scientific Title of Study
|
A randomised controlled clinical trial to study the effect of hingvadi churna in katishula with special reference to sutika roga .
|
| 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 Vama Hitesh Sanghvi |
| Designation |
PG Student |
| Affiliation |
SMBT Ayurved college and hospital |
| Address |
Department of Prasuti Tantra Evum Stri Roga SMBT Ayurved College and Hospital Dhamangaon Nashik
Nashik
Maharashtra
422403
India
Nashik
MAHARASHTRA
422403
India |
| Phone |
9773559985 |
| Fax |
|
| Email |
vamasanghvi110@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sameer S Gholap |
| Designation |
Professor |
| Affiliation |
SMBT Ayurved college and hospital |
| Address |
Department of Prasuti Tantra Evum Stri Roga SMBT Ayurved college and hospital
Dhamangaon Nashik
Nashik
Maharashtra
422403
India
Nashik
MAHARASHTRA
422403
India |
| Phone |
9820304881 |
| Fax |
|
| Email |
drsameer.gholap@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sameer S Gholap |
| Designation |
Professor |
| Affiliation |
SMBT Ayurved college and hospital |
| Address |
Department of Prasuti Tantra Evum Stri Roga SMBT Ayurved college and hospital
Dhamangaon Nashik
Nashik
Maharashtra
422403
India
Nashik
MAHARASHTRA
422403
India |
| Phone |
9820304881 |
| Fax |
|
| Email |
drsameer.gholap@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Prasuti Tantra Evum Stri Roga SMBT ayurved college and hospital Nandi hills igatpuri dhamangaon nashik 422403
Nashik
Maharashtra
India |
|
|
Primary Sponsor
|
| Name |
Dr Vama Hitesh Sanghvi |
| Address |
Department of Prasuti Tantra Evum Stri Roga SMBT Ayurved college and Hospital Dhamangaon Nashik
Nashik 422403
Maharashtra
India
|
| 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 Vama Hitesh Sanghvi |
SMBT ayurved hospital |
OPD no 04 Department of Prasuti Tantra evum Stri roga
Nashik
MAHARASHTRA |
9773559985
vamasanghvi110@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMBT ayurved college and hospital |
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: SUTIKAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Hingvadi churna , Reference: Bhaisajya ratnavali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -koshnajal), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Chaturbeej churna, Reference: Bhavprakash nighantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -koshnajal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
The signs and the Symptoms of puerperal women after normal delivery
Full-term normal delivery irrespective of parity and gravida
Married women.
Patients between 18 -35 years of age.
Patient willing to give written consent
|
|
| ExclusionCriteria |
| Details |
L.S.C.S.
Previous operations
Patients with known case of Spine disorders
Patients with Any previous surgeries/ lumbar / abdominal surgery
Patients unwilling to give informed written consent.
Age group below 18 years and above 35 years.
High-risk pregnancies associated with known case of PIH, Pre- Eclampsia, Eclampsia, PPH, CPD.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of hingvadi churna in katishula with special reference to sutika roga with the help of assessment criteria after 14 days of treatment |
Reduction in signs and symptoms of katishula in sutika after 14 days of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study effectiveness of trial and control group |
18 months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
05/08/2024 |
| 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 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
|
Womens health is crucial not only for the individual but also for the society. In
today’s society, postpartum women face various health issues due to lifestyle
changes, stress, and strain Many mothers complain of physical problems like back
pain and joint pain after delivery. Sutika katishula is commonest condition. It can be a cause of many Abnormal dietics or lifestyle or because of improper garbhini paricharya or sutika paricharya. The prevalence rate of sutika katishula is 33.33%.In modern science, treatment of katishula is analgesics which subside the pain temporarily and causes side effect if used for a longer period of time as well as affects
baby through breast feeding. In ayurveda the main aim is vatahara which in turn ( pacifies the vata) and
increasing the agni. Line of treatment is vatahara and agnidipana. Hingavadi churna has same properties. The contents of this drug are easily available and cost effective and has more efficient properties to cure sutika katishula. The clinical study of Hingavadi churna has not been yet accessed in sutika katishula so it will help to fill knowledge gap. Study includes the female patient having sign and symptoms of sutika katishula between age group of 18-35 year who fulfill terms of inclusion criteria. Written consent is taken from patient to ensure ethical compliance and transparency in research process. Total Sample size is 70 and is calculated by using Daniel 1999 formula. 35 patients in each group. Simple random sampling technique will be used. Total number of patients is 70 which is divided into two groups named as Group A ( trial group) and group B ( control group). Hingvadi churna is given to group A ( Trial group ) and chaturbeej churna is given to group B ( control group). Drugs will be purchased from GMP certified pharmacy. Both drugs will be administered for 14 days. All SOP of churna preparation will be followed throughout the clinical trial. Observation will be done on 0th day, 7th day and 14th day. Scale used for assessment will be Oswestry Disability Index scale. Results will be drawn on the basis of assessment criteria and Statistical analysis.Discussion will be carried out on the basis of observation and result obtained during treatment. Summary will be drawn and the thesis work will be summarized with the help of statistical analysis. Conclusion will be drawn out. |