| CTRI Number |
CTRI/2024/07/069950 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
26/11/2025 |
| 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
|
Study In Participants Of Palitya(greying of hair) With Reference To Rasavaha Srota Dusthi due to Stress (related to Overthinking) And A Comparative Trial With Intervention Of Shankhpushpi Syrup As An Add On Therapy to Kasmaryadi Taila. |
|
Scientific Title of Study
|
A CASE CONTROL STUDY OF PALITYA IN THE CONTEXT OF RASAVAHINI DUSYANTI CINTYANAM CATICINTANAT AND RANDOMIZED CONTROLLED TRIAL OF SHANKHPUSHPI SYRUP AS AN ADD ON THERAPY OF KASMARYADI TAILA |
| 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 ASHA KUMAWAT |
| Designation |
PG SCHOLAR |
| Affiliation |
National Institute of Ayurveda, Deemed to be University (De-novo) |
| Address |
Department of Rog Nidana Evem Vikriti Vigyana, OPD Room No. 17 and Central Lab National Institute of Ayurveda, Jorawar Singh Gate,Amer Road
Jaipur
RAJASTHAN
302002
India |
| Phone |
9468688479 |
| Fax |
|
| Email |
jaishreeshyam479@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR REETU SHARMA |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda, Deemed to be University (De-novo) |
| Address |
Department of Rog Nidana Evem Vikriti Vigyana, OPD Room No. 17 and Central Lab National Institute of Ayurveda, Jorawar Singh Gate,Amer Road,Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8368960978 |
| Fax |
|
| Email |
drreetusharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR REETU SHARMA |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda, Deemed to be University (De-novo) |
| Address |
Department of Rog Nidana Evem Vikriti Vigyana, OPD Room No. 17 and Central Lab National Institute of Ayurveda, Jorawar Singh Gate,Amer Road,Jaipur
RAJASTHAN
302002
India |
| Phone |
8368960978 |
| Fax |
|
| Email |
drreetusharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda, Jorawar Singh Gate,Amer Road,Jaipur, 302002 Rajasthan |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
Jorawar Singh Gate,Amer Road,Jaipur, 302002 Rajasthan |
| Type of Sponsor |
Government medical college |
|
|
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 Asha Kumawat |
National Institute of Ayurveda |
Department of Rog Nidana Evem Vikriti Vigyana, OPD Room No. 17 and Central Lab National Institute of Ayurveda, Jorawar Singh Gate,Amer Road,Jaipur
Jaipur
RAJASTHAN |
9468688479
jaishreeshyam479@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE NATIONAL INSTITUTE OF AYURVEDA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E639||Nutritional deficiency, unspecified. Ayurveda Condition: AKALAPALITAH/PALITAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: KASMARYADI TAILA , Reference: YOGRATNAKAR, VAIDYA LAKSMIPATI SASTRI, CHAUKHAMBA PRAKASHAN – KSHUDRA ROGA, CIKITSHA PRAKARAN PALITA CIKITSHA 5, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: SHANKHPUSHPI SYRUP, Reference: CHARAK CIKITSHA RASAYANA 1-3 / 30, 36, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients having grey hairs more than 10 % and upto 75 % |
|
| ExclusionCriteria |
| Details |
1. Individuals with any known hormonal imbalance problems.
2. Any kind of fungal or other infection of scalp.
Pregnant ladies.
3. Other skin disorders like Psoriasis, Eczema,Leucoderma, Seborrhic Dermatitis.
4. Individuals of Pitta Pradhan Prakriti.
5. Individuals giving consent to not use dye/hair colour /bleach during the trial period.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in GSS (greying severity score) in both groups before and after treatment |
Changes will be observed in 0, 15 and 30 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in clinical signs & symptoms of Palitya in both groups before & after treatment
sign & symptoms of Palitya like keÅ›a varṇa (color of the hair), ruká¹£a & sphuá¹ita keÅ›a (Dry & split hair), kapÄladÄha (Burning sensation in the scalp), svedapravá¹›ti on forehead & scalp(sweatning) |
Changes will be observed in 0, 15 & 30 Days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
05/08/2024 |
| Date of Study Completion (India) |
10/09/2025 |
| Date of First Enrollment (Global) |
05/08/2024 |
| Date of Study Completion (Global) |
10/09/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
PHASE
1 : Case Control study ( Nidanatmaka study )
Case
Control Study :
Research
Question:
Is
there any association between Rasavahini Dusyanti Cintyanam Caticintanat and
Palitya on the basis of perseverative thinking questionnaire?
Hypothesis
:
Null
Hypothesis : There is no association between Rasavahini Dusyanti Cintyanam
Caticintanat and Palitya on the basis of perseverative thinking
questionnaire.
Alternate
Hypothesis : There is association between Rasavahini Dusyanti Cintyanam
Caticintanat and Palitya on the basis of perseverative thinking questionnaire.
AIMS
AND OBJECTIVES:
Aim:
To
evaluate association between Rasavahini Dusyanti cintyanam caticintanat and
Palitya on the basis of perseverative thinking questionnaire.
Objectives
:
To
find out the association between Rasavahini Dusyanti cintyanam caticintanat and
Palitya on the basis of perseverative thinking questionnaire
PHASE
2 : Randomized Comparative Trial
Research
Question :
What
is the effect of locally applied Kasmaryadi Taila with and without oral
administration of Shankhpushpi Syrup in terms of change in Greying Severity
Score (GSS) in Palitya before and after treatment that is i.e. day 0, 15, 30?
Hypothesis
:
Null
hypothesis :
There
is no difference between the effect of locally applied Kasmaryadi Tail with and
without oral administration of Shankhpushpi Syrup in terms of change in Greying
Severity Score (GSS) in Palitya.
Alternate
hypothesis :
There
is difference between the effect of locally applied Kasmaryadi Taila with and
without oral administration of Shankhpushpi Syrup in terms of change in Greying
Severity Score (GSS) in Palitya.
AIMS
AND OBJECTIVES :
Aim
:
To
assess the add on effect of orally given Shankhpushpi Syrup with locally
applied Kasmaryadi Taila in terms of change in baseline GSS (greying
Severity Score) before and after completion of therapy.
Objectives
:
Primary
Objective:
To
compare the therapeutic efficacy of locally applied Kasmaryadi Taila as
compared to with and without oral administration of Shankhpushpi Syrup in terms
of change in Greying Severity Score (GSS) in Palitya.
Secondary
Objective:
To
assess the changes in clinical signs and symptoms of Palitya before and after
treatment that is i.e. day 0,15,30. |