| CTRI Number |
CTRI/2023/07/055029 [Registered on: 10/07/2023] Trial Registered Prospectively |
| Last Modified On: |
06/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Shirishadi Malhar & Parushakadi
Yog in the Management of KIKKISA w.s.r. to STRIAE GRAVIDARUM" |
|
Scientific Title of Study
|
“A Clinical Study to Evaluate the Efficacy of the Shirishadi Malhar & Parushakadi
Yog in the Management of KIKKISA w.s.r. to STRIAE GRAVIDARUM" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Soni Kapil |
| Designation |
MD Ayu, Ph.D,reader |
| Affiliation |
RGGPG Ayurvedic college paprola,Kangra |
| Address |
RGGPG Ayurvedic College and Hospital, Paprola PG Department of
Prasuti Tantra avum Stree Roga
Kangra
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
7018240789 |
| Fax |
|
| Email |
skbhardwaj73@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Soni kapil |
| Designation |
MD Ayu, Ph.D,reader |
| Affiliation |
RGGPG Ayurvedic college paprola,Kangra |
| Address |
RGGPG Ayurvedic College and Hospital, Paprola PG Department of
Prasuti Tantra avum Stree Roga
Kangra
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
7018240789 |
| Fax |
|
| Email |
skbhardwaj73@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanskrati Nema |
| Designation |
MS Scholar |
| Affiliation |
RGGPG Ayurvedic college paprola,Kangra |
| Address |
RGGPG Ayurvedic College and Hospital, Paprola PG Department of
Prasuti Tantra avum Stree Roga
Kangra
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8965024825 |
| Fax |
|
| Email |
sanskratin@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Pharmacy, RGGPG Ayurvedic College and Hospital, Paprola, Dist.Kangra, HP,
Reseaarch in ISM Jogindernagar,Dist.Mandi, HP |
|
|
Primary Sponsor
|
| Name |
Government of Himachal Pradesh |
| Address |
RGGPG Ayurvedic College and Hospital, Paprola, Kangra, HP |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| HOD Department of Prasuti Tantra avum Stree Roga |
RGGPG Ayurvedic College and Hospital,
Paprola, 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 Soni Kapil |
RGGPG Ayurvedic College and Hospital |
OPD and IPD of
Department of Prasuti
Tantra avum Stree roga,
RGGPG Ayurvedic College
and Hospital, Paprola,
Kangra, HP
Kangra
HIMACHAL PRADESH
Kangra
HIMACHAL PRADESH |
9418499799
skbhardwaj73@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC (human) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L929||Granulomatous disorder of the skinand subcutaneous tissue, unspecified. Ayurveda Condition: KIKKISA-GARBINIROGAH, (2) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: KIKKISA-GARBINIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shirishadi malhar, Reference: Charak samhita sharir 8/32, Route: Topical, Dosage Form: Kalka/ Paste , Dose: 3(g), Frequency: bd, Bhaishajya Kal: Muhurmuhu, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Parushakadi Yog, Reference: Astang Hridaya sutra 10/22-24, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Navneet), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Period of pregnancy between 24-32 weeks.
2.Both Primi & multi gravida having classical sign & symptoms of Kikkisa w.s.r. to
Striae Gravidarum. |
|
| ExclusionCriteria |
| Details |
1.Age below 20 & above 40 yrs.
2. Any type of skin disease other than Kikkisa.
3.Associated Systemic diseases like Tuberculosis, Jaundice etc. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| overall symptomatic improvement will be assessed by applying Modified Atwal Score of striae gravidarum |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Establishment of Shirishadi Malhara & Parushakadi Yoga in the management of Kikkisa or Striae gravidarum |
1-1/2 year |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
02/08/2023 |
| 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
|
Research report will be soon published after the completion of trial 200 patients fulfiling the Inclusion and exclusion criterias will be randomly selected from the OPD and IPD of Department of Prasuti Tantra evum Stree Roga , RGGPG Ayurvedic College and Hospital , Paprola. Patients will be divided into two groups of 100 each .Study group I - Shirishadi Malhar for local application .Study group II - Shirishadi Malhar for local application & Parushakadi Yog orally.Duration of trial will be 2 months , Three follow ups .Patients will be followed up monthly for 2 months. 1st follow up after completion of 1 month of trial & 2nd follow up after completion of trial & last follow up after one month of drug free period. The patient treated in trial group will be assessed by presence or absence of signs and symptoms before and after treatment. |