| CTRI Number |
CTRI/2024/12/078715 [Registered on: 30/12/2024] Trial Registered Prospectively |
| Last Modified On: |
27/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Curative] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical study of Tiktadi Ghrita Ointment on stretchmarks in pregnant women |
|
Scientific Title of Study
|
Pharmaceutico-analytical study and clinical evaluation of Tiktadi Ghrita Ointment in Kikkisa with special reference to Striae gravidarum: A Randomized Controlled Trial |
| 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 Alka Gajanan Khade |
| Designation |
PG Scholar |
| Affiliation |
Shri Ayurveda Mahavidyalaya, Nagpur |
| Address |
Rasashastra and Bhaishajyakalpana Department,
Pakwasa Samanvay Rugnalaya,
Shri Ayurved Mahavidyalaya,
Hanuman Nagar, Nagpur 440024,
Maharashtra, India
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9075677028 |
| Fax |
|
| Email |
alkakhade98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raman Belge |
| Designation |
Head of department |
| Affiliation |
Shri Ayurveda Mahavidyalaya, Nagpur |
| Address |
Rasashastra and Bhaishajyakalpana Department,
Pakwasa Samanvay Rugnalaya,
Shri Ayurved Mahavidyalaya,
Hanuman Nagar, Nagpur 440024,
Maharashtra, India
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9822879010 |
| Fax |
|
| Email |
ramanbelge@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Raman Belge |
| Designation |
Head of department |
| Affiliation |
Shri Ayurveda Mahavidyalaya, Nagpur |
| Address |
Rasashastra and Bhaishajyakalpana Department,
Pakwasa Samanvay Rugnalaya,
Shri Ayurved Mahavidyalaya,
Hanuman Nagar, Nagpur 440024,
Maharashtra, India
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9822879010 |
| Fax |
|
| Email |
ramanbelge@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pakwasa Samanvay Rugnalaya,
Shri Ayurved Mahavidyalaya,
Hanuman Nagar, Nagpur,pincode- 440024,Nagpur,Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Dr Alka Gajanan Khade |
| Address |
Rasashastra and Bhaishajyakalpana Department,
Pakwasa Samanvay Rugnalaya,
Shri Ayurved Mahavidyalaya,
Hanuman Nagar, Nagpur 440024,
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 Alka Gajanan Khade |
Shri Ayurveda Mahavidyalaya,Nagpur |
Rasashastra and Bhaishajyakalpana Department,
Pakwasa Samanvay Rugnalaya,
Shri Ayurved Mahavidyalaya,
Hanuman Nagar, Nagpur,pincode- 440024,Nagpur,Maharashtra, India
Nagpur
MAHARASHTRA |
9075677028
alkakhade98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri Ayurveda Mahavidyalaya,Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O268||Other specified pregnancy relatedconditions. Ayurveda Condition: KIKKISA-GARBINIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Karveer Taila, Reference: Charak Samhita,Sharir Sthan,Jatisutriya sharir adhyaya 08/32, Route: Topical, Dosage Form: Taila, Dose: 2(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Tiktadi Ghrita Ointment, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Tikatdi Ghrita is mentioned in Yogratnakar for Vran savarnikaran.The Tikatdi Ghrita is modified into Tiktadi Ghrita ointment. |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Patients willingly participating in the trial and giving consent form.
• Selection of patient will be Primigravida only.
• Women diagnosed with symptoms of Kikkisa –
1. Vaivarnya (Discoloration)
2. Kandu (Itching)
3. Vidah(Burning sensation)
4. Rekha Swarupa Twak Sankocha (Linear line marking and contractions of the skin in the abdomen). |
|
| ExclusionCriteria |
| Details |
1.Women suffering from any other skin diseases except Kikkisa.
2.Known case of any systemic illness like tuberculosis,HIV, Hepatitis B,
Hepatitis C, Diabetes mellitus, Hyperbilirubinemia,etc
3.Presence of any surgical scar on the abdomen.
4.High-risk pregnancy. (multiple pregnancy, pregnancy induced hypertension, Polyhydramnios, etc.) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pharmaceutico-analytical Studies of Tiktadi Ghrita Ointment |
6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This study may prove Tiktadi Ghrita Ointment as effective treatment in the management of Kikkisa |
Follow up on 15th,30th & 45th Day |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/01/2025 |
| 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
|
In the present study, total 64 participants will be taken for trial dividing them in 2 equal groups. Grp-A will receive the trial drug ’Tiktadi Ghrita Ointment’and Grp-B will receive the controlled drug ’Karveer Taila’ for external application for 45 days. Follow up will be taken on Day-15,30,45. Result will be concluded based on assessment criteria. |